510(k) K062774
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2006
- Date Received
- September 18, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Warmer, Blood, Non-Electromagnetic Radiation
- Device Class
- Class II
- Regulation Number
- 864.9205
- Review Panel
- HE
- Submission Type