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FDA 510(k)

HEART AID MODEL 97

K-Number: K850170 · 1985-02-14

ApplicantCardiac Resucitator Corp.
Decision Date1985-02-14
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART AID MODEL 97 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Resucitator Corp.. It received FDA 510(k) clearance on 1985-02-14 under 510(k) number K850170. 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 HEART AID MODEL 97?

HEART AID MODEL 97 is a medical device that received FDA 510(k) clearance on 1985-02-14. The listed applicant is Cardiac Resucitator Corp.. The 510(k) number is K850170.

When did HEART AID MODEL 97 receive FDA 510(k) clearance?

HEART AID MODEL 97 received FDA 510(k) clearance on 1985-02-14, under 510(k) number K850170.

Who is the listed applicant for HEART AID MODEL 97?

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

What is the FDA product code for HEART AID MODEL 97?

The FDA product code for HEART AID MODEL 97 is DRO.

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Other records listing Cardiac Resucitator 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.

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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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