The following data is part of a premarket notification filed by Medison America, Inc. with the FDA for 6.5 Mhz Endorectal Convex Array (10r) Probe.
| Device ID | K953773 |
| 510k Number | K953773 |
| Device Name: | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton, CA 94566 |
| Contact | Mark F Hayward |
| Correspondent | Mark F Hayward MEDISON AMERICA, INC. 5880 WEST LAS POSITAS BLVD., SUITE 52 Pleasanton, CA 94566 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-14 |
| Decision Date | 1996-03-14 |