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FDA 510(k)

OCR II & OCM II

K-Number: K942989 · 1995-07-07

Decision Date1995-07-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OCR II & OCM II is the device name listed in this FDA 510(k) record. The listed applicant is Chambermaid Products Co.. It received FDA 510(k) clearance on 1995-07-07 under 510(k) number K942989. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCR II & OCM II?

OCR II & OCM II is a medical device that received FDA 510(k) clearance on 1995-07-07. The listed applicant is Chambermaid Products Co.. The 510(k) number is K942989.

When did OCR II & OCM II receive FDA 510(k) clearance?

OCR II & OCM II received FDA 510(k) clearance on 1995-07-07, under 510(k) number K942989.

Who is the listed applicant for OCR II & OCM II?

The FDA 510(k) record lists Chambermaid Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCR II & OCM II?

The FDA product code for OCR II & OCM II is FLE.

Related Devices (Code: FLE)

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.

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.

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