The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for 7.5 Mhz Endovaginal Probe.
Device ID | K870709 |
510k Number | K870709 |
Device Name: | 7.5 MHZ ENDOVAGINAL PROBE |
Classification | Transducer, Ultrasonic, Obstetric |
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 | HGL |
CFR Regulation Number | 884.2960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-20 |
Decision Date | 1987-03-27 |