Thermometer, Exacta Temp
FDA 510(k) K781106 · S.M.B. Celsius Co., Inc.
510(k) numberK781106
Submission
- Device name
- Thermometer, Exacta Temp
- Applicant
- S.M.B. Celsius Co., Inc.
Mchenry, IL, US - Received
- July 3, 1978
- Decision date
- August 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLK – Thermometer, Clinical Mercury
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2920
- Specialty
- General Hospital
Other 510(k)s with product code FLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960185 | Amsino Clinical ThermometerFLK · Traditional | Amsia Intl., Inc. | 03/28/1996SE |
| K960224 | Geratherm Mercuiry Free Clinical ThermometerFLK · Traditional | Rg Ent., Inc. | 03/25/1996SE |
| K953465 | KentempFLK · Traditional | Kentron Health Care, Inc. | 12/15/1995SE |
| K942483 | Clinical Glass ThermometerFLK · Traditional | Makol Medical Instruments Corp. | 03/28/1995SE |
| K941673 | Mediaid Universal ThermometerFLK · Traditional | Polymedica Industries, Inc. | 08/25/1994SE |
| K940394 | Amg Med Brand Clinical Glass ThermometerFLK · Traditional | Technolab Industries (Canada) , Ltd. | 05/04/1994SE |
| K940380 | Amg Med Brand Clinical Glass ThermometerFLK · Traditional | Amg Medical, Inc. | 05/04/1994SE |
| K932991 | Guardian and Andino ModelsFLK · Traditional | Coltemp, Inc. | 01/28/1994SE |
| K923225 | Lorrex Health Products - Clinical Mercury ThermomeFLK · Traditional | Lorrex Health Products | 06/08/1993SE |
| K913793 | Simpex Inc. Oral and Rectal ThermometersFLK · Traditional | Simpex, Inc. | 12/30/1991SE |
Questions and answers
When was Thermometer, Exacta Temp cleared by the FDA?
Thermometer, Exacta Temp (K781106) received a 510(k) decision of Substantially Equivalent on August 10, 1978, 38 days after the submission was received.
What is the product code of K781106?
The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.