HANDMASTER— 510(k) K010837

Name: FDA 510(k) clearance K010837
Creator: U.S. Food and Drug Administration
Published: 2001-06-15

Substantially Equivalent

Neuromusclar Electrical Stimulation Systems, Ltd.

FDA 510(k) clearance K010837 for HANDMASTER, Substantially Equivalent on 2001-06-15. Applicant: Neuromusclar Electrical Stimulation Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Neuromusclar Electrical Stimulation Systems, Ltd.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2001-03-20
Decision date: 2001-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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