510(k) K882266
K882266 is an FDA 510(k) premarket notification submitted by Ats Co. for the device "DIGITAL EMG MONITOR MYOTRON 120". The FDA issued a decision of Substantially Equivalent on Aug 15, 1988. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 15, 1988
- Date Received
- May 31, 1988
- 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