Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
FDA 510(k) clearance K200943 · decided 2021-12-17
Clearance details
- K-number
- K200943
- Device name
- Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
- Applicant
- Circa Scientific, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-04-08
- Decision date
- 2021-12-17
- Days to decision
- 618 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.