The following data is part of a premarket notification filed by Bobes S.a. with the FDA for Bobes Tonometer.
| Device ID | K945446 |
| 510k Number | K945446 |
| Device Name: | BOBES TONOMETER |
| Classification | Tonometer, Manual |
| Applicant | BOBES S.A. CTRA. FUENTE DEL TORO, S/N 28710 EL MOLAR Madrid, ES |
| Contact | Francisco J Bobes Naves |
| Correspondent | Francisco J Bobes Naves BOBES S.A. CTRA. FUENTE DEL TORO, S/N 28710 EL MOLAR Madrid, ES |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-06-20 |