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510(k) K023147

ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 by Bortec Biomedical, Ltd. — Product Code IKN

K023147 is an FDA 510(k) premarket notification submitted by Bortec Biomedical, Ltd. for the device "ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4". The FDA issued a decision of Substantially Equivalent on December 12, 2002. The device falls under product code IKN (Electromyograph, Diagnostic), a Class II device regulated under 21 CFR 890.1375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2002
Date Received
September 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

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  • K113074 — CMAP PRO (February 2, 2012)
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FDA data resources