The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for 7.5 Mhz Transrectal (endorectal) Probe.
| Device ID | K870748 |
| 510k Number | K870748 |
| Device Name: | 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-25 |
| Decision Date | 1987-04-10 |