SLENDERTONE FLEX, MODEL, 512— 510(k) K010335

Name: FDA 510(k) clearance K010335
Creator: U.S. Food and Drug Administration
Published: 2001-09-27

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K010335 for SLENDERTONE FLEX, MODEL, 512, Substantially Equivalent on 2001-09-27. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2001-02-02
Decision date: 2001-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington Dc, DC, US

Download summary PDF View on FDA.gov ↗

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