510(k) K213650
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2022
- Date Received
- November 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Telethermographic (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2980
- Review Panel
- RA
- Submission Type