The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Iu22 Diagnostic Ultrasound System.
| Device ID | K130499 |
| 510k Number | K130499 |
| Device Name: | IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 -8431 |
| Contact | Jessica Stenberg |
| Correspondent | Jessica Stenberg PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 -8431 |
| 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 | No |
| Combination Product | No |
| Date Received | 2013-02-26 |
| Decision Date | 2013-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067981 | K130499 | 000 |
| 00884838061729 | K130499 | 000 |
| 00884838061743 | K130499 | 000 |
| 00884838061774 | K130499 | 000 |
| 00884838061781 | K130499 | 000 |
| 00884838064577 | K130499 | 000 |
| 00884838064584 | K130499 | 000 |
| 00884838064614 | K130499 | 000 |
| 00884838067493 | K130499 | 000 |
| 00884838067509 | K130499 | 000 |
| 00884838067523 | K130499 | 000 |
| 00884838067547 | K130499 | 000 |
| 00884838067561 | K130499 | 000 |
| 00884838067615 | K130499 | 000 |
| 00884838067639 | K130499 | 000 |
| 00884838067684 | K130499 | 000 |
| 00884838067967 | K130499 | 000 |
| 00884838025172 | K130499 | 000 |