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FDA 510(k)

CATHETER, NASAL, OXYGEN

K-Number: K902420 · 1991-04-17

ApplicantGainor Medical Europe, Ltd.
Decision Date1991-04-17
Product CodeCAT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CATHETER, NASAL, OXYGEN is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1991-04-17 under 510(k) number K902420. The device is classified under product code CAT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, NASAL, OXYGEN?

CATHETER, NASAL, OXYGEN is a medical device that received FDA 510(k) clearance on 1991-04-17. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902420.

When did CATHETER, NASAL, OXYGEN receive FDA 510(k) clearance?

CATHETER, NASAL, OXYGEN received FDA 510(k) clearance on 1991-04-17, under 510(k) number K902420.

Who is the listed applicant for CATHETER, NASAL, OXYGEN?

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

What is the FDA product code for CATHETER, NASAL, OXYGEN?

The FDA product code for CATHETER, NASAL, OXYGEN is CAT.

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Other records listing Gainor Medical Europe, 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.

K926448I.V. ADMINISTRATION SETK931828CARELET SAFETY LANCETK931827CLEANLET, CLEANLET XL & KIDSK922441SURESEAL BANDAGEK913333I.V. PRIMING SETK902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLE

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Related Devices (Code: CAT)

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.

K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIHudson Respiratory Care, Inc.K935533NASAL CANNULAPuritas Health Care, Inc.K9223974 SURE TM NASAL OXYGEN CANNULABoston Pacific Medical, Inc.K921496SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIEDAlpine Specialties, Inc.K920573CANNULA NASAL OXYGENB & F Medical Products, Inc.K913421NASAL OXYGEN CANNULA, 81585, 81587 & 81589Specialty Packaging Producs, Inc.

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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