The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Clearvue 350/550 Diagnostic Ultrasound System.
| Device ID | K120321 |
| 510k Number | K120321 |
| Device Name: | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS HEALTHCARE 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 | 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 | 2012-02-02 |
| Decision Date | 2012-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080775 | K120321 | 000 |
| 00884838061385 | K120321 | 000 |
| 00884838033450 | K120321 | 000 |
| 00884838033443 | K120321 | 000 |
| 00884838026124 | K120321 | 000 |
| 00884838026117 | K120321 | 000 |
| 00884838097711 | K120321 | 000 |
| 00884838097704 | K120321 | 000 |
| 00884838097681 | K120321 | 000 |
| 00884838061392 | K120321 | 000 |
| 00884838061408 | K120321 | 000 |
| 00884838061415 | K120321 | 000 |
| 00884838080713 | K120321 | 000 |
| 00884838080706 | K120321 | 000 |
| 00884838075672 | K120321 | 000 |
| 00884838073623 | K120321 | 000 |
| 00884838067424 | K120321 | 000 |
| 00884838061484 | K120321 | 000 |
| 00884838061460 | K120321 | 000 |
| 00884838061453 | K120321 | 000 |
| 00884838097667 | K120321 | 000 |