TRANSAMERICAN CLASSIC TENS— 510(k) K944280

Name: FDA 510(k) clearance K944280
Creator: U.S. Food and Drug Administration
Published: 1995-05-15

Substantially Equivalent

Transamerica Biomedical, Inc.

FDA 510(k) clearance K944280 for TRANSAMERICAN CLASSIC TENS, Substantially Equivalent on 1995-05-15. Applicant: Transamerica Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Transamerica Biomedical, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1994-08-30
Decision date: 1995-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Hadley, MA, US

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