Emg Biofeedback Device
FDA 510(k) K823511 · Nemectron Medical, Inc.
510(k) numberK823511
Submission
- Device name
- Emg Biofeedback Device
- Applicant
- Nemectron Medical, Inc.
Walker, MI, US - Received
- November 29, 1982
- Decision date
- March 31, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Emg Biofeedback Device cleared by the FDA?
Emg Biofeedback Device (K823511) received a 510(k) decision of Substantially Equivalent on March 31, 1983, 122 days after the submission was received.
What is the product code of K823511?
The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.