The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Cilco Sonometrics Digicon.
| Device ID | K854653 |
| 510k Number | K854653 |
| Device Name: | CILCO SONOMETRICS DIGICON |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Contact | David Krapf |
| Correspondent | David Krapf COOPERVISION, INC. 17701 COWAN AVE.P. O. BOX 19587 Irvine, CA 92713 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1986-09-04 |