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FDA 510(k)

EMERGIPACE - EXTERNAL PACEMAKER

K-Number: K850812 · 1985-11-05

ApplicantLife Science Instrumentation, Inc.
Decision Date1985-11-05
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMERGIPACE - EXTERNAL PACEMAKER is the device name listed in this FDA 510(k) record. The listed applicant is Life Science Instrumentation, Inc.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K850812. 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 EMERGIPACE - EXTERNAL PACEMAKER?

EMERGIPACE - EXTERNAL PACEMAKER is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Life Science Instrumentation, Inc.. The 510(k) number is K850812.

When did EMERGIPACE - EXTERNAL PACEMAKER receive FDA 510(k) clearance?

EMERGIPACE - EXTERNAL PACEMAKER received FDA 510(k) clearance on 1985-11-05, under 510(k) number K850812.

Who is the listed applicant for EMERGIPACE - EXTERNAL PACEMAKER?

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

What is the FDA product code for EMERGIPACE - EXTERNAL PACEMAKER?

The FDA product code for EMERGIPACE - EXTERNAL PACEMAKER is DRO.

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Other records listing Life Science Instrumentation, Inc. as applicant

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K842037LS 5K843396LS-260G MONITOR/RECORDER & DEFIBILLATORK840246MINI-DEFIBRILLATOR 280/4K831056DEFIBRILLATOR VPD 545K822617VPD540 DEFIBRILLATORK822616LS6 ARRYTHMIA DISCRIMINATOR

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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.

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