The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Boris Platform Diagnostic Ultrasound System.
| Device ID | K030455 |
| 510k Number | K030455 |
| Device Name: | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 |
| Contact | Lynn Harmer |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| 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 | 2003-02-11 |
| Decision Date | 2003-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082953 | K030455 | 000 |
| 00884838024304 | K030455 | 000 |
| 00884838024649 | K030455 | 000 |
| 00884838064553 | K030455 | 000 |
| 00884838064652 | K030455 | 000 |
| 00884838073524 | K030455 | 000 |
| 00884838075146 | K030455 | 000 |
| 00884838075177 | K030455 | 000 |
| 00884838080782 | K030455 | 000 |
| 00884838080799 | K030455 | 000 |
| 00884838081109 | K030455 | 000 |
| 00884838082496 | K030455 | 000 |
| 00884838082908 | K030455 | 000 |
| 00884838082915 | K030455 | 000 |
| 00884838082922 | K030455 | 000 |
| 00884838082939 | K030455 | 000 |
| 00884838023987 | K030455 | 000 |