510(k) K864345
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1987
- Date Received
- November 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Temperature Discrimination
- Device Class
- Class I
- Regulation Number
- 882.1200
- Review Panel
- NE
- Submission Type