Myotone Emg Monitor
FDA 510(k) K772005 · Micro Tronics Corp.
510(k) numberK772005
Submission
- Device name
- Myotone Emg Monitor
- Applicant
- Micro Tronics Corp.
Mchenry, IL, US - Received
- October 21, 1977
- Decision date
- November 23, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|
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| K863124 | Model 8 EEG PreamplifierGWQ · Traditional | 11/18/1986SE |
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Questions and answers
When was Myotone Emg Monitor cleared by the FDA?
Myotone Emg Monitor (K772005) received a 510(k) decision of Substantially Equivalent on November 23, 1977, 33 days after the submission was received.
What is the product code of K772005?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.