510(k) K831995
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1983
- Date Received
- June 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Temperature Measurement, Direct Contact, Powered
- Device Class
- Class II
- Regulation Number
- 882.1570
- Review Panel
- NE
- Submission Type