The following data is part of a premarket notification filed by Info-chem with the FDA for Thermometer Recal Adapter.
Device ID | K772233 |
510k Number | K772233 |
Device Name: | THERMOMETER RECAL ADAPTER |
Classification | Thermometer, Clinical Color Change |
Applicant | INFO-CHEM 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FQZ |
CFR Regulation Number | 880.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-07 |
Decision Date | 1977-12-20 |