ENRAF-NONIUS SONOPULS 190 SYSTEM— 510(k) K000084

Name: FDA 510(k) clearance K000084
Creator: U.S. Food and Drug Administration
Published: 2000-08-04

Substantially Equivalent

Henley Healthcare, Inc.

FDA 510(k) clearance K000084 for ENRAF-NONIUS SONOPULS 190 SYSTEM, Substantially Equivalent on 2000-08-04. Applicant: Henley Healthcare, Inc.. Device class: 2.

Clearance details

Applicant: Henley Healthcare, Inc.
Product code: Code IMI
Device class: Class 2
Regulation: 21 CFR 890.5300
Advisory panel: Physical Medicine
Date received: 2000-01-12
Decision date: 2000-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

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