The following data is part of a premarket notification filed by Philips Ultrasound Llc with the FDA for 5000 Compact Series Ultrasound Systems (ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 Cv, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W).
| Device ID | K222648 |
| 510k Number | K222648 |
| Device Name: | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021 |
| Contact | Shilpa Rapaka |
| 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 |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-09-01 |
| Decision Date | 2022-09-27 |