510(k) K823511
K823511 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "EMG BIOFEEDBACK DEVICE". The FDA issued a decision of Substantially Equivalent on Mar 31, 1983. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Nemectron Medical, Inc. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 1983
- Date Received
- Nov 29, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Biofeedback
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type
- 510(k) Exempt