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 |