The following data is part of a premarket notification filed by Regitar U.s.a., Inc. with the FDA for Pacifier Thermometer.
| Device ID | K952541 |
| 510k Number | K952541 |
| Device Name: | PACIFIER THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | REGITAR U.S.A., INC. 2776 GUTNER PARK DRIVE EAST Montgomery, AL 36109 |
| Contact | Y. T. Tsai |
| Correspondent | Y. T. Tsai REGITAR U.S.A., INC. 2776 GUTNER PARK DRIVE EAST Montgomery, AL 36109 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-28 |
| Decision Date | 1996-01-02 |