510(k) K051261
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2005
- Date Received
- May 16, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Infrared, Therapeutic Heating
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- PM
- Submission Type