The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Basis Digital Thermometer.
| Device ID | K952159 |
| 510k Number | K952159 |
| Device Name: | BASIS DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
| Contact | Julie Chaffee |
| Correspondent | Julie Chaffee POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-08 |
| Decision Date | 1995-09-22 |