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FDA 510(k)

THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)

K-Number: K950175 · 1995-04-18

ApplicantAqua-Air Medical Devices, Inc.
Decision Date1995-04-18
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) is the device name listed in this FDA 510(k) record. The listed applicant is Aqua-Air Medical Devices, Inc.. It received FDA 510(k) clearance on 1995-04-18 under 510(k) number K950175. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)?

THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Aqua-Air Medical Devices, Inc.. The 510(k) number is K950175.

When did THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) receive FDA 510(k) clearance?

THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) received FDA 510(k) clearance on 1995-04-18, under 510(k) number K950175.

Who is the listed applicant for THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)?

The FDA 510(k) record lists Aqua-Air Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)?

The FDA product code for THE AQUA-AIR PROFESSIONAL FIELD UNIT(S) is EIA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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