The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for 3mhz Annular Array.
| Device ID | K864980 |
| 510k Number | K864980 |
| Device Name: | 3MHZ ANNULAR ARRAY |
| Classification | Transducer, 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 | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-05-11 |