The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Iu22 Ultrasound System And Transducers.
| Device ID | K093563 |
| 510k Number | K093563 |
| Device Name: | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 |
| Contact | Nancy Burke |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | 2009-11-18 |
| Decision Date | 2010-02-01 |
| Summary: | summary |