The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Philips Iu22 Ultrasound System.
Device ID | K042540 |
510k Number | K042540 |
Device Name: | PHILIPS IU22 ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 |
Contact | Lynn Harmer |
Product Code | IYO |
Subsequent Product Code | ITX |
Subsequent Product Code | IYN |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-09-20 |
Decision Date | 2004-10-04 |
Summary: | summary |