Computer Dyno/Gonio/Myo Graphy
FDA 510(k) K942965 · Infotronic Medical Engineering
510(k) numberK942965
Submission
- Device name
- Computer Dyno/Gonio/Myo Graphy
- Applicant
- Infotronic Medical Engineering
Severna Park, MD, US - Received
- June 24, 1994
- Decision date
- October 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Computer Dyno/Gonio/Myo Graphy cleared by the FDA?
Computer Dyno/Gonio/Myo Graphy (K942965) received a 510(k) decision of Substantially Equivalent on October 7, 1995, 470 days after the submission was received.
What is the product code of K942965?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.