The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Basis Flexible Tip Digital Thermometer.
| Device ID | K971045 |
| 510k Number | K971045 |
| Device Name: | BASIS FLEXIBLE TIP DIGITAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Contact | Susan Collins |
| Correspondent | Susan Collins POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. 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 | 1997-03-21 |
| Decision Date | 1997-05-02 |
| Summary: | summary |