The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Cx50 Version 2.0 Diagnostic Ultrasound System And Transducers.
| Device ID | K091804 |
| 510k Number | K091804 |
| Device Name: | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Rob Butler |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-06-18 |
| Decision Date | 2009-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087163 | K091804 | 000 |
| 00884838067882 | K091804 | 000 |
| 00884838067875 | K091804 | 000 |
| 00884838067868 | K091804 | 000 |
| 00884838067844 | K091804 | 000 |
| 00884838061668 | K091804 | 000 |
| 00884838061613 | K091804 | 000 |
| 00884838061491 | K091804 | 000 |
| 00884838028098 | K091804 | 000 |