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FDA 510(k)

NASAL CANNULA

K-Number: K935533 · 1994-02-03

ApplicantPuritas Health Care, Inc.
Decision Date1994-02-03
Product CodeCAT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASAL CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1994-02-03 under 510(k) number K935533. 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 CANNULA?

NASAL CANNULA is a medical device that received FDA 510(k) clearance on 1994-02-03. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K935533.

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

NASAL CANNULA received FDA 510(k) clearance on 1994-02-03, under 510(k) number K935533.

Who is the listed applicant for NASAL CANNULA?

The FDA 510(k) record lists Puritas Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL CANNULA?

The FDA product code for NASAL CANNULA is CAT.

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Other records listing Puritas Health Care, 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.

K942339SKIN NEUVEAU SCAR TREATMENTK941197SILK*SKIN SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPK940074Y-TYPE BLOOD ADMINISTRATION SETK940055MULTISET

View all 24 devices →

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.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.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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