The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Mediaid Universal Thermometer.
| Device ID | K941673 |
| 510k Number | K941673 |
| Device Name: | MEDIAID UNIVERSAL THERMOMETER |
| Classification | Thermometer, Clinical Mercury |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Contact | Andrew M Reed |
| Correspondent | Andrew M Reed POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Product Code | FLK |
| CFR Regulation Number | 880.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-05 |
| Decision Date | 1994-08-25 |