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FDA 510(k)

ADVANCMED ELIMINATOR

K-Number: K803223 · 1981-01-13

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

Device Summary

ADVANCMED ELIMINATOR 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 K803223. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCMED ELIMINATOR?

ADVANCMED ELIMINATOR 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 K803223.

When did ADVANCMED ELIMINATOR receive FDA 510(k) clearance?

ADVANCMED ELIMINATOR received FDA 510(k) clearance on 1981-01-13, under 510(k) number K803223.

Who is the listed applicant for ADVANCMED ELIMINATOR?

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 ADVANCMED ELIMINATOR?

The FDA product code for ADVANCMED ELIMINATOR is DRT.

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Other records listing American Edwards Laboratories as applicant

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Related Devices (Code: DRT)

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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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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