The following data is part of a premarket notification filed by Safety 1st, Inc. with the FDA for The Safety 1st Digital Pacifier.
| Device ID | K963276 |
| 510k Number | K963276 |
| Device Name: | THE SAFETY 1ST DIGITAL PACIFIER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SAFETY 1ST, INC. 210 BOYLSTON ST. Chestnut Hill, MA 02167 |
| Contact | Paul A Ware |
| Correspondent | Paul A Ware SAFETY 1ST, INC. 210 BOYLSTON ST. Chestnut Hill, MA 02167 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-20 |
| Decision Date | 1996-12-06 |