Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models AMT-16, AMT-8 & AMT-4
FDA 510(k) K023147 · Bortec Biomedical, Ltd.
510(k) numberK023147
Submission
- Device name
- Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models AMT-16, AMT-8 & AMT-4
- Applicant
- Bortec Biomedical, Ltd.
Seattle, WA, US - Received
- September 20, 2002
- Decision date
- December 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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Questions and answers
When was Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models AMT-16, AMT-8 & AMT-4 cleared by the FDA?
Analog Multiplexed Cable Telemetry (Amt) Electromyograph, Models AMT-16, AMT-8 & AMT-4 (K023147) received a 510(k) decision of Substantially Equivalent on December 12, 2002, 83 days after the submission was received.
What is the product code of K023147?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.