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FDA 510(k)

VENTI-GENTLE-HALER(TM)

K-Number: K933915 · 1993-10-28

ApplicantVortran Medical Technology 1, Inc.
Decision Date1993-10-28
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VENTI-GENTLE-HALER(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 1993-10-28 under 510(k) number K933915. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTI-GENTLE-HALER(TM)?

VENTI-GENTLE-HALER(TM) is a medical device that received FDA 510(k) clearance on 1993-10-28. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K933915.

When did VENTI-GENTLE-HALER(TM) receive FDA 510(k) clearance?

VENTI-GENTLE-HALER(TM) received FDA 510(k) clearance on 1993-10-28, under 510(k) number K933915.

Who is the listed applicant for VENTI-GENTLE-HALER(TM)?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTI-GENTLE-HALER(TM)?

The FDA product code for VENTI-GENTLE-HALER(TM) is CAF.

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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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