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FDA 510(k)

ATS ACOUSTIC STANDOFF - WATER BAG

K-Number: K850422 · 1985-03-27

ApplicantAts Laboratories, Inc.
Decision Date1985-03-27
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ATS ACOUSTIC STANDOFF - WATER BAG is the device name listed in this FDA 510(k) record. The listed applicant is Ats Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-27 under 510(k) number K850422. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS ACOUSTIC STANDOFF - WATER BAG?

ATS ACOUSTIC STANDOFF - WATER BAG is a medical device that received FDA 510(k) clearance on 1985-03-27. The listed applicant is Ats Laboratories, Inc.. The 510(k) number is K850422.

When did ATS ACOUSTIC STANDOFF - WATER BAG receive FDA 510(k) clearance?

ATS ACOUSTIC STANDOFF - WATER BAG received FDA 510(k) clearance on 1985-03-27, under 510(k) number K850422.

Who is the listed applicant for ATS ACOUSTIC STANDOFF - WATER BAG?

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

What is the FDA product code for ATS ACOUSTIC STANDOFF - WATER BAG?

The FDA product code for ATS ACOUSTIC STANDOFF - WATER BAG is ITX.

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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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