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FDA 510(k)

ADVANCEMED CCU DOCUMENTOR

K-Number: K803222 · 1981-01-13

ApplicantAmerican Edwards Laboratories
Decision Date1981-01-13
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCEMED CCU DOCUMENTOR 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 1981-01-13 under 510(k) number K803222. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCEMED CCU DOCUMENTOR?

ADVANCEMED CCU DOCUMENTOR is a medical device that received FDA 510(k) clearance on 1981-01-13. The listed applicant is American Edwards Laboratories. The 510(k) number is K803222.

When did ADVANCEMED CCU DOCUMENTOR receive FDA 510(k) clearance?

ADVANCEMED CCU DOCUMENTOR received FDA 510(k) clearance on 1981-01-13, under 510(k) number K803222.

Who is the listed applicant for ADVANCEMED CCU DOCUMENTOR?

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 ADVANCEMED CCU DOCUMENTOR?

The FDA product code for ADVANCEMED CCU DOCUMENTOR is DSH.

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Related Devices (Code: DSH)

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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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