Thermometer Kit
FDA 510(k) K780591 · Abco Dealers, Inc.
510(k) numberK780591
Submission
- Device name
- Thermometer Kit
- Applicant
- Abco Dealers, Inc.
Mchenry, IL, US - Received
- April 10, 1978
- Decision date
- April 19, 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 |
More from Simpex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K905025 | Digital Thermometer KitsFLL · Traditional | 02/07/1991SE |
| K882304 | Digital Thermometer Sheaths (Oral and Rectal)FLL · Traditional | 07/12/1988SE |
| K880892 | Blood Collecting Needle and HoldersFMI · Traditional | 04/21/1988SE |
| K880894 | Allergist SyringesFMF · Traditional | 03/31/1988SE |
| K872875 | Stretch Gauze BandagesNAD · Traditional | 09/04/1987SE |
| K872874 | Microscope Cover GlassesKES · Traditional | 08/10/1987SE |
| K872797 | Non-Skid Shoe CoversFXP · Traditional | 08/04/1987SE |
| K871465 | Thermometer SheathsFLL · Traditional | 05/11/1987SE |
| K862726 | Disposable Shoe Covers and Nurses CapsFXP · Traditional | 08/01/1986SE |
| K862111 | Armboards, Reusable and Disposable · Traditional | 07/08/1986SE |
Questions and answers
When was Thermometer Kit cleared by the FDA?
Thermometer Kit (K780591) received a 510(k) decision of Substantially Equivalent on April 19, 1978, 9 days after the submission was received.
What is the product code of K780591?
The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.