The following data is part of a premarket notification filed by Biosynergy, Inc. with the FDA for Temptrend Peds Axillary Temp. Indicator.
| Device ID | K841913 |
| 510k Number | K841913 |
| Device Name: | TEMPTREND PEDS AXILLARY TEMP. INDICATOR |
| Classification | Strip, Temperature, Forehead, Liquid Crystal |
| Applicant | BIOSYNERGY, INC. 724 WEST ALGONQUIN ROAD Arlington Heights , IL 60005 - |
| Contact | Sharon B Muir |
| Correspondent | Sharon B Muir BIOSYNERGY, INC. 724 WEST ALGONQUIN ROAD Arlington Heights , IL 60005 - |
| Product Code | KPD |
| CFR Regulation Number | 880.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-09 |
| Decision Date | 1984-11-02 |