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)

12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON

K-Number: K910144 · 1991-07-17

ApplicantPhysio-Control Corp.
Decision Date1991-07-17
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1991-07-17 under 510(k) number K910144. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON?

12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON is a medical device that received FDA 510(k) clearance on 1991-07-17. The listed applicant is Physio-Control Corp.. The 510(k) number is K910144.

When did 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON receive FDA 510(k) clearance?

12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON received FDA 510(k) clearance on 1991-07-17, under 510(k) number K910144.

Who is the listed applicant for 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON?

The FDA product code for 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON is LDD.

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 Physio-Control Corp. 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

View all 80 devices →

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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.

↑