The following data is part of a premarket notification filed by Associated Mills, Inc. with the FDA for Pollenex Digital Thermometer T-225.
| Device ID | K850363 |
| 510k Number | K850363 |
| Device Name: | POLLENEX DIGITAL THERMOMETER T-225 |
| 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 |