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FDA 510(k)

OXYGUARD

K-Number: K914978 · 1992-01-10

ApplicantStantex Pty , Ltd.
Decision Date1992-01-10
Product CodeMNK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OXYGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Stantex Pty , Ltd.. It received FDA 510(k) clearance on 1992-01-10 under 510(k) number K914978. 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 OXYGUARD?

OXYGUARD is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Stantex Pty , Ltd.. The 510(k) number is K914978.

When did OXYGUARD receive FDA 510(k) clearance?

OXYGUARD received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914978.

Who is the listed applicant for OXYGUARD?

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

What is the FDA product code for OXYGUARD?

The FDA product code for OXYGUARD is MNK.

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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.

K944049OXYGEN MOUTHGUARDEndovations, Inc.K933537ENCOMPAS COMFORT BLOCK # 0B-10Encompas Unlimited, Inc.K931044OXY-BLOCGi SupplyK924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.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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