The following data is part of a premarket notification filed by Thermoscan, Inc. with the FDA for Thermoscan Instant Thermometer Model Ir-6000.
| Device ID | K954523 |
| 510k Number | K954523 |
| Device Name: | THERMOSCAN INSTANT THERMOMETER MODEL IR-6000 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THERMOSCAN, INC. 10421 PACIFIC CENTER CT. San Diego, CA 92121 |
| Contact | Barbara Stevens |
| Correspondent | Barbara Stevens THERMOSCAN, INC. 10421 PACIFIC CENTER CT. 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 | 1995-09-29 |
| Decision Date | 1996-12-10 |
| Summary: | summary |