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FDA 510(k)

NEB-U-MASK SYSTEM, MODELS 1895, 1896

K-Number: K080230 · 2008-06-09

ApplicantTeleflexmedical, Inc.
Decision Date2008-06-09
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEB-U-MASK SYSTEM, MODELS 1895, 1896 is the device name listed in this FDA 510(k) record. The listed applicant is Teleflexmedical, Inc.. It received FDA 510(k) clearance on 2008-06-09 under 510(k) number K080230. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEB-U-MASK SYSTEM, MODELS 1895, 1896?

NEB-U-MASK SYSTEM, MODELS 1895, 1896 is a medical device that received FDA 510(k) clearance on 2008-06-09. The listed applicant is Teleflexmedical, Inc.. The 510(k) number is K080230.

When did NEB-U-MASK SYSTEM, MODELS 1895, 1896 receive FDA 510(k) clearance?

NEB-U-MASK SYSTEM, MODELS 1895, 1896 received FDA 510(k) clearance on 2008-06-09, under 510(k) number K080230.

Who is the listed applicant for NEB-U-MASK SYSTEM, MODELS 1895, 1896?

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

What is the FDA product code for NEB-U-MASK SYSTEM, MODELS 1895, 1896?

The FDA product code for NEB-U-MASK SYSTEM, MODELS 1895, 1896 is CAF.

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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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