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)

TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM

K-Number: K952659 · 1996-01-11

ApplicantTronomed, Inc.
Decision Date1996-01-11
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tronomed, Inc.. It received FDA 510(k) clearance on 1996-01-11 under 510(k) number K952659. 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 TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM?

TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is Tronomed, Inc.. The 510(k) number is K952659.

When did TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM receive FDA 510(k) clearance?

TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM received FDA 510(k) clearance on 1996-01-11, under 510(k) number K952659.

Who is the listed applicant for TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM?

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

What is the FDA product code for TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM?

The FDA product code for TRONOMATE PATIENT CABLE & LEADWIRE 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 Tronomed, 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.

K853303LIFELINC LEADWIREK853452LIFE LINC PATIENT CABLEK841092HIGH PRESSURE FLEX. CONNECTING TUBINGK7921263&4 WAY PLASTIC STERILE STPCKS. PKG.K792124TANDEM ASSEMBLED 3&4 WAY STOPCOCKSK792128STERILE EXTENSION TUBES INDIV. PKG.

View all 12 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.

↑