MODIFIED TEMPA-DOT THERMOMETER
FDA 510(k) clearance K791574 · decided 1979-09-12
Clearance details
- K-number
- K791574
- Device name
- MODIFIED TEMPA-DOT THERMOMETER
- Applicant
- Info-Chem
- Decision
- Substantially Equivalent
- Date received
- 1979-08-13
- Decision date
- 1979-09-12
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- FQZ
- Device class
- 1
- Regulation number
- 880.2900
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- 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 |
|---|---|---|
| CRY-ACTRACKERCAM (K110305) | Brymill Cryogenic Cystems | 2012-01-13 |
| STERI-AID KIT (K963049) | Steri-Aid, Inc. | 1996-11-12 |
| DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP (K946046) | Deroyal Critical Care, Div. Deroyal Technologies | 1995-07-19 |
| POINT CHECKER COLOR STRIP THERMOMETER (K894893) | Kyowa Medex Co., Ltd. | 1990-04-05 |
| FRANKLIN COLLECTOR(R) (K884612) | Franklin Diagnostics, Inc. | 1989-03-27 |
| TEMPA-DOT CLINICAL THERMOMETER SHEATH (K881286) | Pymah Corp. | 1988-06-08 |
| HEALTHCHECK THERM-STRIP (K863181) | Healthcheck Corp. | 1986-09-11 |
| PEE WEE THERMOMETERS (K853515) | Joel R.L. Ehren Kranz | 1985-10-16 |
| BABY TEMP PACIFIER (K822423) | Trp Energy Sensors, Inc. | 1982-10-13 |
| TEMPO2-I DISPOSABLE THERMOMETERS (K790890) | Airlife, Inc. | 1979-06-27 |
| THERMOMETER RECAL ADAPTER (K772233) | Info-Chem | 1977-12-20 |
| THERMOMETER, SINGLE USE, STRIP, TEMPADOT (K771038) | Organon, Inc. | 1977-06-27 |
Recalls involving this device
No recalls on record reference this clearance.