The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Hdi 5000 Diagnostic Ultrasound System.
| Device ID | K034003 |
| 510k Number | K034003 |
| Device Name: | HDI 5000 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 |
| 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 | 2003-12-24 |
| Decision Date | 2004-01-08 |
| Summary: | summary |