The following data is part of a premarket notification filed by Intelligent Product Limited Co. with the FDA for Paci-temp, Pacifier With Digital Thermometer.
Device ID | K952073 |
510k Number | K952073 |
Device Name: | PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | INTELLIGENT PRODUCT LIMITED CO. 463 NORTH OREM BLVD. Orem, UT 84057 |
Contact | Matthew Kho |
Correspondent | Matthew Kho INTELLIGENT PRODUCT LIMITED CO. 463 NORTH OREM BLVD. Orem, UT 84057 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-02 |
Decision Date | 1995-12-18 |