The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Ultrascan Digital B.
| Device ID | K842757 |
| 510k Number | K842757 |
| Device Name: | ULTRASCAN DIGITAL B |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | COOPERVISION, INC. P.O. BOX 19587 Irvine , CA 92713 - |
| Contact | Douglass G Allen |
| Correspondent | Douglass G Allen COOPERVISION, INC. 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 | 1984-07-16 |
| Decision Date | 1985-01-09 |