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FDA 510(k)

AUQASOOTHE/AQUA MED

K-Number: K915729 · 1992-04-29

ApplicantAquasoothe
Decision Date1992-04-29
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AUQASOOTHE/AQUA MED is the device name listed in this FDA 510(k) record. The listed applicant is Aquasoothe. It received FDA 510(k) clearance on 1992-04-29 under 510(k) number K915729. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUQASOOTHE/AQUA MED?

AUQASOOTHE/AQUA MED is a medical device that received FDA 510(k) clearance on 1992-04-29. The listed applicant is Aquasoothe. The 510(k) number is K915729.

When did AUQASOOTHE/AQUA MED receive FDA 510(k) clearance?

AUQASOOTHE/AQUA MED received FDA 510(k) clearance on 1992-04-29, under 510(k) number K915729.

Who is the listed applicant for AUQASOOTHE/AQUA MED?

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

What is the FDA product code for AUQASOOTHE/AQUA MED?

The FDA product code for AUQASOOTHE/AQUA MED is ISA.

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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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