T.E.N.S. UNIT SIGMA & TX-3— 510(k) K883188

Name: FDA 510(k) clearance K883188
Creator: U.S. Food and Drug Administration
Published: 1988-12-16

Substantially Equivalent

Diamond Medical Equipment, Inc.

FDA 510(k) clearance K883188 for T.E.N.S. UNIT SIGMA & TX-3, Substantially Equivalent on 1988-12-16. Applicant: Diamond Medical Equipment, Inc.. Device class: 2.

Clearance details

Applicant: Diamond Medical Equipment, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1988-07-28
Decision date: 1988-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamaica, NY, US

Download summary PDF View on FDA.gov ↗

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