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 |