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FDA 510(k)

M1 CAPNOGRAPHY MASK

K-Number: K133806 · 2013-12-31

ApplicantMonitor Mask, Inc.
Decision Date2013-12-31
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

M1 CAPNOGRAPHY MASK is the device name listed in this FDA 510(k) record. The listed applicant is Monitor Mask, Inc.. It received FDA 510(k) clearance on 2013-12-31 under 510(k) number K133806. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M1 CAPNOGRAPHY MASK?

M1 CAPNOGRAPHY MASK is a medical device that received FDA 510(k) clearance on 2013-12-31. The listed applicant is Monitor Mask, Inc.. The 510(k) number is K133806.

When did M1 CAPNOGRAPHY MASK receive FDA 510(k) clearance?

M1 CAPNOGRAPHY MASK received FDA 510(k) clearance on 2013-12-31, under 510(k) number K133806.

Who is the listed applicant for M1 CAPNOGRAPHY MASK?

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

What is the FDA product code for M1 CAPNOGRAPHY MASK?

The FDA product code for M1 CAPNOGRAPHY MASK is CCK.

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Related Devices (Code: CCK)

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.

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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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