The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq Series Diagnostic Ultrasound Systems.
| Device ID | K202216 |
| 510k Number | K202216 |
| Device Name: | EPIQ Series Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Colin S. Jacob |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | OBJ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-06 |
| Decision Date | 2020-09-02 |