510(k) K151333
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 2015
- Date Received
- May 19, 2015
- 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