The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Hd11 Diagnostic Ultrasound System.
| Device ID | K043535 |
| 510k Number | K043535 |
| Device Name: | HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 3000 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Steve Singlar |
| 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 | 2004-12-22 |
| Decision Date | 2005-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838076754 | K043535 | 000 |
| 00884838068070 | K043535 | 000 |