510(k) K952797
K952797 is an FDA 510(k) premarket notification submitted by Stoelting Co. for the device "AT53 DUAL CHANNEL EMG". The FDA issued a decision of Substantially Equivalent on Apr 17, 1996. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Stoelting Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 1996
- Date Received
- Jun 19, 1995
- 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