The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Diatek Model 700 Thermometer.
Device ID | K895703 |
510k Number | K895703 |
Device Name: | DIATEK MODEL 700 THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | DIATEK, INC. 5720 OBERLIN DR. San Diego, CA 92121 -1723 |
Contact | C Richardson |
Correspondent | C Richardson DIATEK, INC. 5720 OBERLIN DR. San Diego, CA 92121 -1723 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-09-22 |
Decision Date | 1989-12-07 |