Advantage Emg System, Model #A100
FDA 510(k) K974010 · Advantage Medical Division of Cme Telemetrix
510(k) numberK974010
Submission
- Device name
- Advantage Emg System, Model #A100
- Applicant
- Advantage Medical Division of Cme Telemetrix
London, CA - Received
- October 21, 1997
- Decision date
- January 16, 1998
- 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 Advantage Emg System, Model #A100 cleared by the FDA?
Advantage Emg System, Model #A100 (K974010) received a 510(k) decision of Substantially Equivalent on January 16, 1998, 87 days after the submission was received.
What is the product code of K974010?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.