510(k) K941325
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1994
- Date Received
- March 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Caloric-Air
- Device Class
- Class I
- Regulation Number
- 874.1800
- Review Panel
- EN
- Submission Type