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)

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC

K-Number: K874447 · 1988-01-27

ApplicantMedac, Inc.
Decision Date1988-01-27
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC is the device name listed in this FDA 510(k) record. The listed applicant is Medac, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K874447. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC?

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Medac, Inc.. The 510(k) number is K874447.

When did DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC receive FDA 510(k) clearance?

DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC received FDA 510(k) clearance on 1988-01-27, under 510(k) number K874447.

Who is the listed applicant for DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC?

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

What is the FDA product code for DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC?

The FDA product code for DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC is DRO.

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 Medac, 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.

K874319MONITOR, ELECTROGRAPHICK874090300M ECG MONITRO/TRANSCUTANEOUS PACEMAKERK874091360D DC DEFIBRILLATORK871176PACE 10 NON-INVASIVE EXTERNAL PACEMAKERK864985DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCEK864987DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

View all 10 devices →

Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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.

↑