Product code FLK
- Device name
- Thermometer, Clinical Mercury
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.2920
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960185 | AMSINO CLINICAL THERMOMETER | Amsia Intl., Inc. | 1996-03-28 |
| K960224 | GERATHERM MERCUIRY FREE CLINICAL THERMOMETER | Rg Ent., Inc. | 1996-03-25 |
| K953465 | KENTEMP | Kentron Health Care, Inc. | 1995-12-15 |
| K942483 | CLINICAL GLASS THERMOMETER | Makol Medical Instruments Corp. | 1995-03-28 |
| K941673 | MEDIAID UNIVERSAL THERMOMETER | Polymedica Industries, Inc. | 1994-08-25 |
| K940394 | AMG MED BRAND CLINICAL GLASS THERMOMETER | Technolab Industries (Canada) , Ltd. | 1994-05-04 |
| K940380 | AMG MED BRAND CLINICAL GLASS THERMOMETER | Amg Medical, Inc. | 1994-05-04 |
| K932991 | GUARDIAN AND ANDINO MODELS | Coltemp, Inc. | 1994-01-28 |
| K923225 | LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME | Lorrex Health Products | 1993-06-08 |
| K913793 | SIMPEX INC. ORAL AND RECTAL THERMOMETERS | Simpex, Inc. | 1991-12-30 |
| K911269 | MERCURY AND GLASS FEVER THERMOMETER | Steridyne Corp. | 1991-05-15 |
| K902625 | CLINICAL THERMOMETER; RECTAL/ORAL, INNER ARMPIT | Liaoning-Usa Corp. | 1990-10-26 |
| K903500 | MASCOT THERMOTER | Mascot, Inc. | 1990-10-09 |
| K901790 | THERMOMETER, MERCURY/CLINICAL | Perlink USA, Inc. | 1990-07-11 |
| K900646 | MERCURY THERMOMETERS (ORAL AND RECTAL) | Abel Industries, Inc. | 1990-07-11 |
| K897054 | CLINICAL MERCURY THERMOMETER | Cypress Medical Products, Ltd. | 1990-03-22 |
| K893602 | GLASS MERCURY FILLED THERMOMETERS | Smith & Nephew United, Inc. | 1989-08-08 |
| K883573 | THERMOMETER, MERCURY/CLINICAL | Umax Corp. | 1988-11-07 |
| K870285 | THERMOMETER SHEATHES, STERILE (GLASS) | The Medical Group, Inc. | 1987-02-12 |
| K852301 | INOX THERMOMETER JAR | Broadwest Corp. | 1985-07-01 |
| K822502 | DISPOSABLE THERMOMETERS | Hudson Oxygen Therapy Sales Co. | 1982-09-24 |
| K813424 | THERMOMETERS | Abco Dealers, Inc. | 1981-12-18 |
| K813423 | THERMOMETER SHEATHS | Abco Dealers, Inc. | 1981-12-18 |
| K811631 | THERMOMETER (MADE IN CHINA) | Robert I. Chien & Assoc., Inc. | 1981-07-20 |
| K801791 | FERTILITY AWARENESS METHOD KIT | Telesis Corp. | 1980-10-31 |
| K792426 | DISPOSABLE TEMPERATURE PROBE | Hospitak, Inc. | 1980-01-16 |
| K790891 | TEMPO2-II DISPOSABLE THERMOMETERS | Airlife, Inc. | 1979-06-27 |
| K781817 | OVU-GUIDE | Reproduction Research Laboratories | 1978-12-04 |
| K781106 | THERMOMETER, EXACTA TEMP | S.M.B. Celsius Co., Inc. | 1978-08-10 |
| K780591 | THERMOMETER KIT | Abco Dealers, Inc. | 1978-04-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00057475220495 | BIOS Diagnostics | Thermor Ltd | 2023-09-20 |
| 10057475220492 | BIOS Diagnostics | Thermor Ltd | 2023-09-20 |
| 04018674454681 | Geratherm® classic | Geratherm Medical AG | 2023-09-06 |
| 06972543480103 | Disposable Thermometer Cover and Sheaths | KANG ZE INDUSTRIAL CO., LTD | 2019-08-23 |
| 06972543480110 | Disposable Thermometer Cover and Sheaths | KANG ZE INDUSTRIAL CO., LTD | 2019-08-23 |
| 06972543480127 | Disposable Thermometer Cover and Sheaths | KANG ZE INDUSTRIAL CO., LTD | 2019-08-23 |
| 60614801400703 | GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 20614801200619 | Geratherm | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200608 | GERATHERM MERCURY FREE BASAL GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 20614801200510 | GERATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200509 | GERATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 20614801200411 | GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200400 | GERATHERM MAGNATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200301 | GERATHERM MERCURY FREE GLASS ORAL THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 20614801200107 | GERATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801400701 | GERATHERM MERCURY FREE GLASS HYPOTHYROID THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200615 | Geratherm | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200516 | GERATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200417 | GERATHERM MAGNATHERM MERCURY CLINICAL FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |
| 00614801200103 | GERATHERM MERCURY FREE GLASS THERMOMETER | R.G. ENTERPRISES (U.S.A.), INC. | 2016-09-01 |