The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for 7.5 Mhz Endorectal Probe.
| Device ID | K881028 |
| 510k Number | K881028 |
| Device Name: | 7.5 MHZ ENDORECTAL PROBE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 2722 S. FAIRVIEW Santa Ana, CA 92704 |
| Contact | Martin A Kaufman |
| Correspondent | Martin A Kaufman PHILIPS ULTRASOUND, INC. 2722 S. FAIRVIEW Santa Ana, CA 92704 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-10 |
| Decision Date | 1988-04-27 |