510(k) K921885
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1994
- Date Received
- April 21, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heater, Perineal, Direct Contact
- Device Class
- Class II
- Regulation Number
- 884.5390
- Review Panel
- OB
- Submission Type