The following data is part of a premarket notification filed by Thermoscan, Inc. with the FDA for Thermoscan Instant Thermometer Ir-5000.
| Device ID | K930680 |
| 510k Number | K930680 |
| Device Name: | THERMOSCAN INSTANT THERMOMETER IR-5000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THERMOSCAN, INC. 10309 PACIFIC CENTER COURT San Diego, CA 92121 |
| Contact | Lacyne Y Avery |
| Correspondent | Lacyne Y Avery THERMOSCAN, INC. 10309 PACIFIC CENTER COURT 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 | 1993-02-10 |
| Decision Date | 1994-07-20 |