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FDA 510(k)

OXYGEN MOUTHGUARD

K-Number: K944049 · 1994-10-11

ApplicantEndovations, Inc.
Decision Date1994-10-11
Product CodeMNK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OXYGEN MOUTHGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Endovations, Inc.. It received FDA 510(k) clearance on 1994-10-11 under 510(k) number K944049. The device is classified under product code MNK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MOUTHGUARD?

OXYGEN MOUTHGUARD is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Endovations, Inc.. The 510(k) number is K944049.

When did OXYGEN MOUTHGUARD receive FDA 510(k) clearance?

OXYGEN MOUTHGUARD received FDA 510(k) clearance on 1994-10-11, under 510(k) number K944049.

Who is the listed applicant for OXYGEN MOUTHGUARD?

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

What is the FDA product code for OXYGEN MOUTHGUARD?

The FDA product code for OXYGEN MOUTHGUARD is MNK.

Related Clinical Trials

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Related Devices (Code: MNK)

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.

K933537ENCOMPAS COMFORT BLOCK # 0B-10Encompas Unlimited, Inc.K931044OXY-BLOCGi SupplyK924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.K914978OXYGUARDStantex Pty , Ltd.K896691BITE BLOCKEndoscopix

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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