The following data is part of a premarket notification filed by Phakosystems, Inc. with the FDA for Vision Care/phakosystems Echorule.
| Device ID | K871938 |
| 510k Number | K871938 |
| Device Name: | VISION CARE/PHAKOSYSTEMS ECHORULE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PHAKOSYSTEMS, INC. 490 CHAMPAGNE DR. Downsview M3j 2t9, CA |
| Contact | Keith L Carter |
| Correspondent | Keith L Carter PHAKOSYSTEMS, INC. 490 CHAMPAGNE DR. Downsview M3j 2t9, CA |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-18 |
| Decision Date | 1987-11-23 |