ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4— 510(k) K023147

Name: FDA 510(k) clearance K023147
Creator: U.S. Food and Drug Administration
Published: 2002-12-12

Substantially Equivalent

Bortec Biomedical, Ltd.

FDA 510(k) clearance K023147 for ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4, Substantially Equivalent on 2002-12-12. Applicant: Bortec Biomedical, Ltd.. Device class: 2.

Clearance details

Applicant: Bortec Biomedical, Ltd.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2002-09-20
Decision date: 2002-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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