The following data is part of a premarket notification filed by Ge Medical System Israel Ltd. with the FDA for Vivid I Diagnostic Ultrasound System.
Device ID | K102388 |
510k Number | K102388 |
Device Name: | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GE MEDICAL SYSTEM ISRAEL LTD. 9900 INNOVATION DR Wauwatosa, WI 53226 |
Contact | Bryan Behn |
Correspondent | Bryan Behn GE MEDICAL SYSTEM ISRAEL LTD. 9900 INNOVATION DR Wauwatosa, WI 53226 |
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 | No |
Combination Product | No |
Date Received | 2010-08-23 |
Decision Date | 2010-11-04 |
Summary: | summary |