The following data is part of a premarket notification filed by Djinnii Industires, Inc. with the FDA for Liquid Crystal Therm. 8 Event Monitor.
Device ID | K802778 |
510k Number | K802778 |
Device Name: | LIQUID CRYSTAL THERM. 8 EVENT MONITOR |
Classification | Strip, Temperature, Forehead, Liquid Crystal |
Applicant | DJINNII INDUSTIRES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KPD |
CFR Regulation Number | 880.2200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-05 |
Decision Date | 1981-01-09 |