The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Vision Care/phakosystems Echopach.
| Device ID | K880081 |
| 510k Number | K880081 |
| Device Name: | VISION CARE/PHAKOSYSTEMS ECHOPACH |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada, CA M3j 2t9 |
| Contact | Keith L Carter |
| Correspondent | Keith L Carter PHAKOSYSTEMS, INC. 522 CHAMPAGNE DR. DOWNSVIEW, ONTARIO Canada, CA M3j 2t9 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-11 |
| Decision Date | 1988-03-15 |