The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Pachymeter System V.
| Device ID | K864336 |
| 510k Number | K864336 |
| Device Name: | PACHYMETER SYSTEM V |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Contact | Michael Andrews |
| Correspondent | Michael Andrews COOPERVISION, INC. COOPERVISION CILCO 3190 160TH AVENUE S.E. Bellevue, WA 98008 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1987-01-09 |