The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Basis Baby-temp Pacifier Digital Therometer.
| Device ID | K962991 |
| 510k Number | K962991 |
| Device Name: | BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PL. Golden, CO 80401 |
| Contact | Julie Chaffee |
| Correspondent | Julie Chaffee 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 | 1996-08-01 |
| Decision Date | 1996-09-12 |
| Summary: | summary |