DCATS
FDA 510(k) clearance K812799 · decided 1981-10-20
Clearance details
- K-number
- K812799
- Device name
- DCATS
- Applicant
- Dorex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-06
- Decision date
- 1981-10-20
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- IYM
- Device class
- 3
- Regulation number
- 884.2980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, 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.
| Record | Firm | Date |
|---|---|---|
| FMS MODEL 110 (K863736) | Flir Medical Systems | 1986-12-29 |
| VISITHERM (K852950) | C.D. Regelin & Associates, Inc. | 1986-02-07 |
| JEOL MODEL #JTG-500M (K823041) | Jeol | 1982-11-24 |
| ORTHO-THERM INFRARED SENSOR (K812701) | Orthion Corp. | 1981-10-13 |
| THERMOCOMP (K801553) | Hospital Financial Corp. | 1980-10-31 |
| GRAPHIC STRESS TELETHERMOMETRY (K800491) | Gst Laboratories of Ca, Inc. | 1980-03-04 |
| THERMOGRAPH, MEDICAL (K760999) | Honeywell, Inc. | 1976-11-19 |
Recalls involving this device
No recalls on record reference this clearance.