The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Hd11 Diagnostic Ultrasound System.
| Device ID | K062247 |
| 510k Number | K062247 |
| 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 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-08-03 |
| Decision Date | 2006-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838087170 | K062247 | 000 |
| 00884838067516 | K062247 | 000 |
| 00884838064621 | K062247 | 000 |
| 00884838064607 | K062247 | 000 |
| 00884838064560 | K062247 | 000 |
| 00884838061811 | K062247 | 000 |
| 00884838061798 | K062247 | 000 |
| 00884838061767 | K062247 | 000 |
| 00884838061712 | K062247 | 000 |
| 00884838061361 | K062247 | 000 |
| 00884838061354 | K062247 | 000 |
| 00884838061347 | K062247 | 000 |
| 00884838067530 | K062247 | 000 |
| 00884838067608 | K062247 | 000 |
| 00884838067622 | K062247 | 000 |
| 00884838068001 | K062247 | 000 |
| 00884838067974 | K062247 | 000 |
| 00884838067936 | K062247 | 000 |
| 00884838067929 | K062247 | 000 |
| 00884838067738 | K062247 | 000 |
| 00884838067714 | K062247 | 000 |
| 00884838067707 | K062247 | 000 |
| 00884838067691 | K062247 | 000 |
| 00884838067677 | K062247 | 000 |
| 00884838067653 | K062247 | 000 |
| 00884838067646 | K062247 | 000 |
| 00884838025196 | K062247 | 000 |