The following data is part of a premarket notification filed by Thermoscan, Inc. with the FDA for Braun Thermoscan Pro-2000 Instant Thermometer (pro-2000).
| Device ID | K964605 |
| 510k Number | K964605 |
| Device Name: | BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | THERMOSCAN, INC. 10421 PACIFIC CENTER CT. San Diego, CA 92121 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison 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 | 1996-11-18 |
| Decision Date | 1997-05-16 |
| Summary: | summary |