Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM

K-Number: K940323 · 1995-04-12

ApplicantArbo Medical, Inc.
Decision Date1995-04-12
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arbo Medical, Inc.. It received FDA 510(k) clearance on 1995-04-12 under 510(k) number K940323. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM?

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM is a medical device that received FDA 510(k) clearance on 1995-04-12. The listed applicant is Arbo Medical, Inc.. The 510(k) number is K940323.

When did ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM receive FDA 510(k) clearance?

ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM received FDA 510(k) clearance on 1995-04-12, under 510(k) number K940323.

Who is the listed applicant for ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM?

The FDA 510(k) record lists Arbo Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM?

The FDA product code for ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM is DSA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Arbo Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935437ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODESK942905DISPOSABLE TEMPERATURE PROBE COVERK940302ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEMK940322ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIREK935246ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODESK935429ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES

View all 15 devices →

Related Devices (Code: DSA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254114Baylis Connector CableBaylis Medical Technologies, Inc.K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)Drägerwerk AG & Co. KGaAK251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterShanghai Draeger Medical Instrument Co., Ltd.K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, SnPhilips Medizin Systeme Böblingen GmbHK240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑