510(k) K031116
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2003
- Date Received
- April 8, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5300
- Review Panel
- PM
- Submission Type