510(k) K941938
K941938 is an FDA 510(k) premarket notification submitted by Intercare Diagnostics, Inc. for the device "THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Intercare Diagnostics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1994
- Date Received
- April 21, 1994
- 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