The following data is part of a premarket notification filed by Medical Frontiers, Inc. with the FDA for Tempalert Liquid Crystal Thermometer.
Device ID | K850797 |
510k Number | K850797 |
Device Name: | TEMPALERT LIQUID CRYSTAL THERMOMETER |
Classification | Strip, Temperature, Forehead, Liquid Crystal |
Applicant | MEDICAL FRONTIERS, INC. 7560 MCEWEN RD. Centerville, OH 45459 |
Contact | Thomas L Glass |
Correspondent | Thomas L Glass MEDICAL FRONTIERS, INC. 7560 MCEWEN RD. Centerville, OH 45459 |
Product Code | KPD |
CFR Regulation Number | 880.2200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-27 |
Decision Date | 1985-04-05 |