The following data is part of a premarket notification filed by Science Development Corp. with the FDA for Qt-100 Electronic Temp. Monitor.
Device ID | K832391 |
510k Number | K832391 |
Device Name: | QT-100 ELECTRONIC TEMP. MONITOR |
Classification | Thermometer, Electronic, Clinical |
Applicant | SCIENCE DEVELOPMENT 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 | 1983-07-19 |
Decision Date | 1983-09-12 |