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FDA 510(k)

HEART *AID, #80

K-Number: K820609 · 1982-08-06

ApplicantCardiac Resucitator Corp.
Decision Date1982-08-06
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART *AID, #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 1982-08-06 under 510(k) number K820609. 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, #80?

HEART *AID, #80 is a medical device that received FDA 510(k) clearance on 1982-08-06. The listed applicant is Cardiac Resucitator Corp.. The 510(k) number is K820609.

When did HEART *AID, #80 receive FDA 510(k) clearance?

HEART *AID, #80 received FDA 510(k) clearance on 1982-08-06, under 510(k) number K820609.

Who is the listed applicant for HEART *AID, #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, #80?

The FDA product code for HEART *AID, #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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