The following data is part of a premarket notification filed by North American Philips Corp. with the FDA for Electronic Digital Fever Thermometer.
Device ID | K833755 |
510k Number | K833755 |
Device Name: | ELECTRONIC DIGITAL FEVER THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | NORTH AMERICAN PHILIPS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-26 |
Decision Date | 1984-01-30 |