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FDA 510(k)

Besmed PEEP Valve

K-Number: K160112 · 2016-04-29

ApplicantBesmed Health Business Corp
Decision Date2016-04-29
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Besmed PEEP Valve is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K160112. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Besmed PEEP Valve?

Besmed PEEP Valve is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Besmed Health Business Corp. The 510(k) number is K160112.

When did Besmed PEEP Valve receive FDA 510(k) clearance?

Besmed PEEP Valve received FDA 510(k) clearance on 2016-04-29, under 510(k) number K160112.

Who is the listed applicant for Besmed PEEP Valve?

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

What is the FDA product code for Besmed PEEP Valve?

The FDA product code for Besmed PEEP Valve is BYE.

Other records listing Besmed Health Business Corp as applicant

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.

K241339Besmed Bacterial Filter and HMEFK172804Besmed Peak Flow Meter

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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