The following data is part of a premarket notification filed by Micro Weiss Electronics with the FDA for Pro Check Digital Pacifier Thermometer.
| Device ID | K972259 |
| 510k Number | K972259 |
| Device Name: | PRO CHECK DIGITAL PACIFIER THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MICRO WEISS ELECTRONICS 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-17 |
| Decision Date | 1997-07-10 |
| Summary: | summary |