Mediaid Universal Thermometer
FDA 510(k) K941673 · Polymedica Industries, Inc.
510(k) numberK941673
Submission
- Device name
- Mediaid Universal Thermometer
- Applicant
- Polymedica Industries, Inc.
Golden,, CO, US - Received
- April 5, 1994
- Decision date
- August 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K911269 | Mercury and Glass Fever ThermometerFLK · Traditional | Steridyne Corp. | 05/15/1991SE |
More from Steridyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K964398 | Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing TintedMGP · Traditional | 10/24/1997SE |
| K971045 | Basis Flexible Tip Digital ThermometerFLL · Traditional | 05/02/1997SE |
| K964701 | Mitraflex Pigmented Wound DressingFRO · Traditional | 02/07/1997SE |
| K963623 | Spyroflex Pigmented Wound DressingMGP · Traditional | 10/25/1996SE |
| K962991 | Basis Baby-Temp Pacifier Digital TherometerFLL · Traditional | 09/12/1996SE |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | 11/29/1995SE |
| K952756 | Medi-Aid Basal ThermometerLHD · Traditional | 09/25/1995SE |
| K952159 | Basis Digital ThermometerFLL · Traditional | 09/22/1995SE |
| K953618 | Spyroflex Wound DressingMGP · Traditional | 08/21/1995SN |
Questions and answers
When was Mediaid Universal Thermometer cleared by the FDA?
Mediaid Universal Thermometer (K941673) received a 510(k) decision of Substantially Equivalent on August 25, 1994, 142 days after the submission was received.
What is the product code of K941673?
The FDA product code is FLK – Thermometer, Clinical Mercury, a Class II (moderate risk) device regulated under 21 CFR 880.2920.