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 |