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FDA 510(k)

NASAL ONE

K-Number: K852628 · 1985-09-18

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

Device Summary

NASAL ONE 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 K852628. 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 NASAL ONE?

NASAL ONE 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 K852628.

When did NASAL ONE receive FDA 510(k) clearance?

NASAL ONE received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852628.

Who is the listed applicant for NASAL ONE?

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 NASAL ONE?

The FDA product code for NASAL ONE is CAT.

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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 TWOK852625OXY-TUBE

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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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