FDA 510(k)

EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES

K-Number: K880205 · 1988-02-04

Decision Date1988-02-04

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-02-04 under 510(k) number K880205. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES?

EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1988-02-04. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K880205.

When did EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES receive FDA 510(k) clearance?

EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES received FDA 510(k) clearance on 1988-02-04, under 510(k) number K880205.

Who is the listed applicant for EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES?

The FDA product code for EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.