The following data is part of a premarket notification filed by Tomey Corp. with the FDA for Al-2000 Combined Biometer And Pachymeter.
| Device ID | K012803 |
| 510k Number | K012803 |
| Device Name: | AL-2000 COMBINED BIOMETER AND PACHYMETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOMEY CORP. 5 TIMBER LN. North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell TOMEY CORP. 5 TIMBER LN. North Reading, MA 01864 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-21 |
| Decision Date | 2002-04-08 |
| Summary: | summary |