The following data is part of a premarket notification filed by Tecnimed S.r.l. with the FDA for Modification To Thermofocus 0800, 0900, 01500 And 0700 Series.
| Device ID | K072108 |
| 510k Number | K072108 |
| Device Name: | MODIFICATION TO 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 | Maria F Griffin |
| Correspondent | Maria F Griffin 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00182097000191 | K072108 | 000 |
| 00182097000139 | K072108 | 000 |
| 00182097000115 | K072108 | 000 |
| 00182097000061 | K072108 | 000 |
| 00182097000054 | K072108 | 000 |