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FDA 510(k)

HUMID-VENT HEPA

K-Number: K112958 · 2012-09-21

ApplicantTeleflex Medical
Decision Date2012-09-21
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HUMID-VENT HEPA is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2012-09-21 under 510(k) number K112958. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMID-VENT HEPA?

HUMID-VENT HEPA is a medical device that received FDA 510(k) clearance on 2012-09-21. The listed applicant is Teleflex Medical. The 510(k) number is K112958.

When did HUMID-VENT HEPA receive FDA 510(k) clearance?

HUMID-VENT HEPA received FDA 510(k) clearance on 2012-09-21, under 510(k) number K112958.

Who is the listed applicant for HUMID-VENT HEPA?

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

What is the FDA product code for HUMID-VENT HEPA?

The FDA product code for HUMID-VENT HEPA is CAH.

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Related Devices (Code: CAH)

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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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