510(k) K813199
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1982
- Date Received
- November 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Temperature, Forehead, Liquid Crystal
- Device Class
- Class II
- Regulation Number
- 880.2200
- Review Panel
- HO
- Submission Type