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FDA 510(k)

ENVIROTENT (BED)

K-Number: K881725 · 1988-11-08

Decision Date1988-11-08
Product CodeFNJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENVIROTENT (BED) is the device name listed in this FDA 510(k) record. The listed applicant is Envirotents, Inc.. It received FDA 510(k) clearance on 1988-11-08 under 510(k) number K881725. The device is classified under product code FNJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVIROTENT (BED)?

ENVIROTENT (BED) is a medical device that received FDA 510(k) clearance on 1988-11-08. The listed applicant is Envirotents, Inc.. The 510(k) number is K881725.

When did ENVIROTENT (BED) receive FDA 510(k) clearance?

ENVIROTENT (BED) received FDA 510(k) clearance on 1988-11-08, under 510(k) number K881725.

Who is the listed applicant for ENVIROTENT (BED)?

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

What is the FDA product code for ENVIROTENT (BED)?

The FDA product code for ENVIROTENT (BED) is FNJ.

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: FNJ)

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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