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FDA 510(k)

LITETOUCH MASK

K-Number: K100285 · 2010-06-29

ApplicantRespironics New Jersey, Inc.
Decision Date2010-06-29
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LITETOUCH MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics New Jersey, Inc.. It received FDA 510(k) clearance on 2010-06-29 under 510(k) number K100285. 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 LITETOUCH MASK?

LITETOUCH MASK is a medical device that received FDA 510(k) clearance on 2010-06-29. The listed applicant is Respironics New Jersey, Inc.. The 510(k) number is K100285.

When did LITETOUCH MASK receive FDA 510(k) clearance?

LITETOUCH MASK received FDA 510(k) clearance on 2010-06-29, under 510(k) number K100285.

Who is the listed applicant for LITETOUCH MASK?

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

What is the FDA product code for LITETOUCH MASK?

The FDA product code for LITETOUCH MASK is CAF.

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Other records listing Respironics New Jersey, Inc. as applicant

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Official Source

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