510(k) K790890
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1979
- Date Received
- May 7, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thermometer, Clinical Color Change
- Device Class
- Class I
- Regulation Number
- 880.2900
- Review Panel
- HO
- Submission Type