The following data is part of a premarket notification filed by Tecnimed S.r.l. with the FDA for Thermofocus 0800, 0900, 01500 And 0700 Series.
| Device ID | K033790 |
| 510k Number | K033790 |
| Device Name: | THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TECNIMED S.R.L. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula TECNIMED S.R.L. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-04 |
| Decision Date | 2004-06-03 |
| Summary: | summary |