The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Tycos Self-check/digital Fever Thermo.
Device ID | K842132 |
510k Number | K842132 |
Device Name: | TYCOS SELF-CHECK/DIGITAL FEVER THERMO |
Classification | Thermometer, Electronic, Clinical |
Applicant | SYBRON CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-30 |
Decision Date | 1984-07-18 |