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FDA 510(k)

CAPNOMASK

K-Number: K131339 · 2013-11-25

ApplicantMediplus , Ltd.
Decision Date2013-11-25
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOMASK is the device name listed in this FDA 510(k) record. The listed applicant is Mediplus , Ltd.. It received FDA 510(k) clearance on 2013-11-25 under 510(k) number K131339. 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 CAPNOMASK?

CAPNOMASK is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Mediplus , Ltd.. The 510(k) number is K131339.

When did CAPNOMASK receive FDA 510(k) clearance?

CAPNOMASK received FDA 510(k) clearance on 2013-11-25, under 510(k) number K131339.

Who is the listed applicant for CAPNOMASK?

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

What is the FDA product code for CAPNOMASK?

The FDA product code for CAPNOMASK is CCK.

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Other records listing Mediplus , Ltd. 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.

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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

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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