The following data is part of a premarket notification filed by Thermoscan, Inc. with the FDA for Thermoscan-instant Thermometer Model Ir-4000.
| Device ID | K902912 |
| 510k Number | K902912 |
| Device Name: | THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THERMOSCAN, INC. 6295 FERRIS SQUARE, SUITE G San Diego, CA 92121 |
| Contact | Robert P Lackey |
| Correspondent | Robert P Lackey THERMOSCAN, INC. 6295 FERRIS SQUARE, SUITE G San Diego, CA 92121 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-03 |
| Decision Date | 1990-07-24 |