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FDA 510(k)

AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT

K-Number: K935693 · 1994-08-25

ApplicantVortran Medical Technology 1, Inc.
Decision Date1994-08-25
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT 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 1994-08-25 under 510(k) number K935693. 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 AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT?

AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT is a medical device that received FDA 510(k) clearance on 1994-08-25. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K935693.

When did AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT receive FDA 510(k) clearance?

AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT received FDA 510(k) clearance on 1994-08-25, under 510(k) number K935693.

Who is the listed applicant for AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT?

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 AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT?

The FDA product code for AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT is CAF.

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Related Devices (Code: CAF)

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.

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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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