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FDA 510(k)

SONOTOME

K-Number: K990572 · 1999-05-21

ApplicantSonokinetics, Inc.
Decision Date1999-05-21
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

SONOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Sonokinetics, Inc.. It received FDA 510(k) clearance on 1999-05-21 under 510(k) number K990572. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOTOME?

SONOTOME is a medical device that received FDA 510(k) clearance on 1999-05-21. The listed applicant is Sonokinetics, Inc.. The 510(k) number is K990572.

When did SONOTOME receive FDA 510(k) clearance?

SONOTOME received FDA 510(k) clearance on 1999-05-21, under 510(k) number K990572.

Who is the listed applicant for SONOTOME?

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

What is the FDA product code for SONOTOME?

The FDA product code for SONOTOME is LFL.

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Other records listing Sonokinetics, Inc. as applicant

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.

K930629ACRYL-X II SYSTEMK911548ACRYL-X SYSTEM TM

Related Devices (Code: LFL)

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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