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FDA 510(k)

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS

K-Number: K003529 · 2001-02-12

ApplicantEdap Technomed, Inc.
Decision Date2001-02-12
Product CodeLNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS is the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2001-02-12 under 510(k) number K003529. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS?

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS is a medical device that received FDA 510(k) clearance on 2001-02-12. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K003529.

When did SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS receive FDA 510(k) clearance?

SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS received FDA 510(k) clearance on 2001-02-12, under 510(k) number K003529.

Who is the listed applicant for SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS?

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

What is the FDA product code for SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS?

The FDA product code for SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS is LNS.

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Official Source

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