VISIOFOCUS
Thermometer, Electronic, Clinical
TECNIMED S.R.L.
The following data is part of a premarket notification filed by Tecnimed S.r.l. with the FDA for Visiofocus.
Pre-market Notification Details
| Device ID | K122412 |
| 510k Number | K122412 |
| Device Name: | VISIOFOCUS |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TECNIMED S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin TECNIMED S.R.L. 110 E. GRANADA BLVD SUITE 209 Ormond Beach, FL 32176 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-08 |
| Decision Date | 2013-03-13 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00182097000184 | K122412 | 000 |
| 00182097000153 | K122412 | 000 |
| 00182097000443 | K122412 | 000 |
| 00182097000436 | K122412 | 000 |
| 00182097000498 | K122412 | 000 |
| 00182097000474 | K122412 | 000 |
| 00182097000511 | K122412 | 000 |
| 00182097000559 | K122412 | 000 |
| 00182097000696 | K122412 | 000 |
Trademark Results [VISIOFOCUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VISIOFOCUS 79086170 4014540 Live/Registered |
TECNIMED SRL 2010-06-24 |
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