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FDA 510(k)

HEART-AID MODEL 80

K-Number: K843358 · 1984-11-19

ApplicantCardiac Resucitator Corp.
Decision Date1984-11-19
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART-AID MODEL 80 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 1984-11-19 under 510(k) number K843358. 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 80?

HEART-AID MODEL 80 is a medical device that received FDA 510(k) clearance on 1984-11-19. The listed applicant is Cardiac Resucitator Corp.. The 510(k) number is K843358.

When did HEART-AID MODEL 80 receive FDA 510(k) clearance?

HEART-AID MODEL 80 received FDA 510(k) clearance on 1984-11-19, under 510(k) number K843358.

Who is the listed applicant for HEART-AID MODEL 80?

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 80?

The FDA product code for HEART-AID MODEL 80 is DRO.

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Related Devices (Code: DRO)

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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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