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FDA 510(k)

ULTRAQUIET

K-Number: K021202 · 2002-07-13

ApplicantSound Technique System, LLC
Decision Date2002-07-13
Product CodeKLW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ULTRAQUIET is the device name listed in this FDA 510(k) record. The listed applicant is Sound Technique System, LLC. It received FDA 510(k) clearance on 2002-07-13 under 510(k) number K021202. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAQUIET?

ULTRAQUIET is a medical device that received FDA 510(k) clearance on 2002-07-13. The listed applicant is Sound Technique System, LLC. The 510(k) number is K021202.

When did ULTRAQUIET receive FDA 510(k) clearance?

ULTRAQUIET received FDA 510(k) clearance on 2002-07-13, under 510(k) number K021202.

Who is the listed applicant for ULTRAQUIET?

The FDA 510(k) record lists Sound Technique System, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAQUIET?

The FDA product code for ULTRAQUIET is KLW.

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Related Devices (Code: KLW)

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

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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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