DISPOSABLE TEMPERATURE PROBE
FDA 510(k) clearance K792426 · decided 1980-01-16
Clearance details
- K-number
- K792426
- Device name
- DISPOSABLE TEMPERATURE PROBE
- Applicant
- Hospitak, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-28
- Decision date
- 1980-01-16
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- FLK
- Device class
- 2
- Regulation number
- 880.2920
- 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 |
|---|---|---|
| AMSINO CLINICAL THERMOMETER (K960185) | Amsia Intl., Inc. | 1996-03-28 |
| GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (K960224) | Rg Ent., Inc. | 1996-03-25 |
| KENTEMP (K953465) | Kentron Health Care, Inc. | 1995-12-15 |
| CLINICAL GLASS THERMOMETER (K942483) | Makol Medical Instruments Corp. | 1995-03-28 |
| MEDIAID UNIVERSAL THERMOMETER (K941673) | Polymedica Industries, Inc. | 1994-08-25 |
| AMG MED BRAND CLINICAL GLASS THERMOMETER (K940380) | Amg Medical, Inc. | 1994-05-04 |
| AMG MED BRAND CLINICAL GLASS THERMOMETER (K940394) | Technolab Industries (Canada) , Ltd. | 1994-05-04 |
| GUARDIAN AND ANDINO MODELS (K932991) | Coltemp, Inc. | 1994-01-28 |
| LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (K923225) | Lorrex Health Products | 1993-06-08 |
| SIMPEX INC. ORAL AND RECTAL THERMOMETERS (K913793) | Simpex, Inc. | 1991-12-30 |
| MERCURY AND GLASS FEVER THERMOMETER (K911269) | Steridyne Corp. | 1991-05-15 |
| CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT (K902625) | Liaoning-Usa Corp. | 1990-10-26 |
Recalls involving this device
No recalls on record reference this clearance.