The following data is part of a premarket notification filed by Philips Ultrasound, Inc with the FDA for Aaa Model.
| Device ID | K200603 |
| 510k Number | K200603 |
| Device Name: | AAA Model |
| Classification | System, Image Processing, Radiological |
| Applicant | Philips Ultrasound, Inc 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Hebe Sun |
| Correspondent | Hebe Sun Philips Ultrasound, Inc 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-09 |
| Decision Date | 2020-09-20 |