The following data is part of a premarket notification filed by Quantel Medical S.a. with the FDA for Axis Nano Opthalmic Biometer Ultrasound System.
| Device ID | K102027 |
| 510k Number | K102027 |
| Device Name: | AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | QUANTEL MEDICAL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Contact | Michael Johnson |
| Correspondent | Michael Johnson QUANTEL MEDICAL S.A. 601 HAGGERTY LANE Bozeman, MT 59715 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-12-22 |
| Summary: | summary |