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FDA 510(k)

INFINITECH BREATH EZ

K-Number: K935441 · 1994-02-07

ApplicantInfinitech, Inc.
Decision Date1994-02-07
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INFINITECH BREATH EZ is the device name listed in this FDA 510(k) record. The listed applicant is Infinitech, Inc.. It received FDA 510(k) clearance on 1994-02-07 under 510(k) number K935441. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITECH BREATH EZ?

INFINITECH BREATH EZ is a medical device that received FDA 510(k) clearance on 1994-02-07. The listed applicant is Infinitech, Inc.. The 510(k) number is K935441.

When did INFINITECH BREATH EZ receive FDA 510(k) clearance?

INFINITECH BREATH EZ received FDA 510(k) clearance on 1994-02-07, under 510(k) number K935441.

Who is the listed applicant for INFINITECH BREATH EZ?

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

What is the FDA product code for INFINITECH BREATH EZ?

The FDA product code for INFINITECH BREATH EZ is BWN.

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Other records listing Infinitech, 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.

K972506INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORK971950INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTERK951627INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEMK931264INFINITECH OTOPROBEK931546END-IRRIGATING ENDOILLUMINATOR

Related Devices (Code: BWN)

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.

K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, Inc.K884558IOP ADJUSTABLE STIRRUPMend Technologies, 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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