Thermometer (Made in China)
FDA 510(k) K811631 · Robert I. Chien & Assoc., Inc.
510(k) numberK811631
Submission
- Device name
- Thermometer (Made in China)
- Applicant
- Robert I. Chien & Assoc., Inc.
Mchenry, IL, US - Received
- June 9, 1981
- Decision date
- July 20, 1981
- 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 |
More from Simpex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822151 | Surgical Instruments Represent. 4 ClassHNF · Traditional | 08/19/1982SE |
| K811632 | Unsterilized Laparotomy Sponges (China)GDY · Traditional | 09/11/1981SE |
| K810054 | Rica (Diagnostic Instruments)GWZ · Traditional | 01/28/1981SE |
| K801819 | Surgical InstrumentsHXD · Traditional | 08/20/1980SE |
| K801028 | Rica or Smic Surgical InstrumentsHXD · Traditional | 05/20/1980SE |
Questions and answers
When was Thermometer (Made in China) cleared by the FDA?
Thermometer (Made in China) (K811631) received a 510(k) decision of Substantially Equivalent on July 20, 1981, 41 days after the submission was received.
What is the product code of K811631?
The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.