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FDA 510(k)

DERMGARD SYSTEM 800 AND 900

K-Number: K880486 · 1988-02-22

Decision Date1988-02-22
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DERMGARD SYSTEM 800 AND 900 is the device name listed in this FDA 510(k) record. The listed applicant is Dermgard, Inc.. It received FDA 510(k) clearance on 1988-02-22 under 510(k) number K880486. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMGARD SYSTEM 800 AND 900?

DERMGARD SYSTEM 800 AND 900 is a medical device that received FDA 510(k) clearance on 1988-02-22. The listed applicant is Dermgard, Inc.. The 510(k) number is K880486.

When did DERMGARD SYSTEM 800 AND 900 receive FDA 510(k) clearance?

DERMGARD SYSTEM 800 AND 900 received FDA 510(k) clearance on 1988-02-22, under 510(k) number K880486.

Who is the listed applicant for DERMGARD SYSTEM 800 AND 900?

The FDA 510(k) record lists Dermgard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMGARD SYSTEM 800 AND 900?

The FDA product code for DERMGARD SYSTEM 800 AND 900 is IOQ.

Related Clinical Trials

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.

Related Devices (Code: IOQ)

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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