The following data is part of a premarket notification filed by Meda Ltd. with the FDA for Ultrasonic Biometer/pachymeter For Opthalmology Odm 2100 And Odm 2200.
| Device ID | K063433 |
| 510k Number | K063433 |
| Device Name: | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDA LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll MEDA LTD. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-01-29 |
| Summary: | summary |