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FDA 510(k)

4 SURE TM NASAL OXYGEN CANNULA

K-Number: K922397 · 1993-03-18

ApplicantBoston Pacific Medical, Inc.
Decision Date1993-03-18
Product CodeCAT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

4 SURE TM NASAL OXYGEN CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Boston Pacific Medical, Inc.. It received FDA 510(k) clearance on 1993-03-18 under 510(k) number K922397. 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 4 SURE TM NASAL OXYGEN CANNULA?

4 SURE TM NASAL OXYGEN CANNULA is a medical device that received FDA 510(k) clearance on 1993-03-18. The listed applicant is Boston Pacific Medical, Inc.. The 510(k) number is K922397.

When did 4 SURE TM NASAL OXYGEN CANNULA receive FDA 510(k) clearance?

4 SURE TM NASAL OXYGEN CANNULA received FDA 510(k) clearance on 1993-03-18, under 510(k) number K922397.

Who is the listed applicant for 4 SURE TM NASAL OXYGEN CANNULA?

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

What is the FDA product code for 4 SURE TM NASAL OXYGEN CANNULA?

The FDA product code for 4 SURE TM NASAL OXYGEN CANNULA is CAT.

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Other records listing Boston Pacific Medical, Inc. 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.

K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYSK9224024 SURE TM ENTERAL FEEDING BAGK9310484-SURE NELATON CATHETERK9310474-SURE FEMALE CATHETERK9218524 SURE TM RECTAL TUBEK9218534 SURE TM FEEDING TUBES

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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.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.K912197SKIN SAVER(TM) TUBING HOLDER, MODEL 467Alpine Specialties, 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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