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FDA 510(k)

OXY-TUBE

K-Number: K852625 · 1985-09-18

ApplicantAshai Co. , Ltd.
Decision Date1985-09-18
Product CodeCAT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXY-TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ashai Co. , Ltd.. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K852625. 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 OXY-TUBE?

OXY-TUBE is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Ashai Co. , Ltd.. The 510(k) number is K852625.

When did OXY-TUBE receive FDA 510(k) clearance?

OXY-TUBE received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852625.

Who is the listed applicant for OXY-TUBE?

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

What is the FDA product code for OXY-TUBE?

The FDA product code for OXY-TUBE is CAT.

Other records listing Ashai Co. , 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.

K870428AEROSOL ONE, NEBULIZER PUMPK852622AEROSOL ONEK852620SAFE.N.SUREK852627MAXI-NEBK852629AERO-MASK TWOK852618OXY-DIAL

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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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