The following data is part of a premarket notification filed by Quantel Medical with the FDA for Pocket Ultrasonic Ophthalmic Pachymeter, Biometry Transducer For Pocket.
| Device ID | K000554 |
| 510k Number | K000554 |
| Device Name: | POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | QUANTEL MEDICAL 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers QUANTEL MEDICAL 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-18 |
| Decision Date | 2000-03-14 |