510(k) K012011
K012011 is an FDA 510(k) premarket notification submitted by Stoelting Co. for the device "MODIFICATION TO A620 EEG". The FDA issued a decision of Substantially Equivalent on Oct 10, 2001. 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
- Oct 10, 2001
- Date Received
- Jun 28, 2001
- Clearance Type
- Special
- 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