THERMO SENTRY 1200 THERMO-SYS-TS1200
FDA 510(k) clearance K833711 · decided 1984-04-13
Clearance details
- K-number
- K833711
- Device name
- THERMO SENTRY 1200 THERMO-SYS-TS1200
- Applicant
- Clini-Therm Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-20
- Decision date
- 1984-04-13
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLINI-THERM MARK I/IV/ DIPOLE ARRAY APPLICATOR (P840015/S014) | Clini-Therm Corp. | 1990-07-17 |
| CLINI-THERM MARK I/IV (P840015/S013) | Clini-Therm Corp. | 1988-12-15 |
| CLINI-THERM MARK I/IV (P840015/S012) | Clini-Therm Corp. | 1988-08-22 |
| CLINI-THERM MARK I/IV (P840015/S011) | Clini-Therm Corp. | 1988-04-05 |
| CLINI-THERM MARK I/IV (P840015/S010) | Clini-Therm Corp. | 1988-02-29 |
| CLINI-THERM MARK I/IV (P840015/S008) | Clini-Therm Corp. | 1988-02-19 |
| CLINI-THERM MARK I/IV (P840015/S006) | Clini-Therm Corp. | 1988-01-21 |
| CLINI-THERM MARK I/IV (P840015/S009) | Clini-Therm Corp. | 1987-12-29 |