Clinical Thermometer; Rectal/Oral, Inner Armpit
FDA 510(k) K902625 · Liaoning-Usa Corp.
510(k) numberK902625
Submission
- Device name
- Clinical Thermometer; Rectal/Oral, Inner Armpit
- Applicant
- Liaoning-Usa Corp.
Pasadena, CA, US - Received
- June 14, 1990
- Decision date
- October 26, 1990
- 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 |
|---|---|---|
| K911921 | Disposable Isolation GownFYB · Traditional | 05/13/1991SE |
| K905487 | Various Types of StethoscopesLDE · Traditional | 04/09/1991SE |
| K910623 | Gauze Sponges Absorbent Gauze RollsEFQ · Traditional | 04/01/1991SE |
| K892781 | Antelope Brand Patient Examination GlovesLYY · Traditional | 09/21/1989SE |
| K892774 | Patient Examination GlovesLYY · Traditional | 09/13/1989SE |
Questions and answers
When was Clinical Thermometer; Rectal/Oral, Inner Armpit cleared by the FDA?
Clinical Thermometer; Rectal/Oral, Inner Armpit (K902625) received a 510(k) decision of Substantially Equivalent on October 26, 1990, 134 days after the submission was received.
What is the product code of K902625?
The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.