The following data is part of a premarket notification filed by Polymedica Healthcare, Inc. with the FDA for Fever Monitoring Kit.
| Device ID | K931747 |
| 510k Number | K931747 |
| Device Name: | FEVER MONITORING KIT |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | POLYMEDICA HEALTHCARE, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
| Contact | Robert J Zappa |
| Correspondent | Robert J Zappa POLYMEDICA HEALTHCARE, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1993-12-13 |