The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Pollenex Digital Thermometer T-125.
Device ID | K850362 |
510k Number | K850362 |
Device Name: | POLLENEX DIGITAL THERMOMETER T-125 |
Classification | Thermometer, Electronic, Clinical |
Applicant | ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
Contact | Rossier |
Correspondent | Rossier ASSOCIATED MILLS, INC. 165 NORTH CANAL ST. Chicago, IL 60606 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-30 |
Decision Date | 1985-02-15 |