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FDA 510(k)

CARDIAC 1000 TM

K-Number: K811094 · 1981-07-28

ApplicantAmerican Edwards Laboratories
Decision Date1981-07-28
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC 1000 TM is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K811094. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC 1000 TM?

CARDIAC 1000 TM is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is American Edwards Laboratories. The 510(k) number is K811094.

When did CARDIAC 1000 TM receive FDA 510(k) clearance?

CARDIAC 1000 TM received FDA 510(k) clearance on 1981-07-28, under 510(k) number K811094.

Who is the listed applicant for CARDIAC 1000 TM?

The FDA 510(k) record lists American Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC 1000 TM?

The FDA product code for CARDIAC 1000 TM is JAA.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: JAA)

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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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