The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics L with the FDA for Vivid Iq.
Device ID | K161706 |
510k Number | K161706 |
Device Name: | Vivid Iq |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L 9900 W. INNOVATION DR. Wauwatosa, WI 53226 |
Contact | Tracey Ortiz |
Correspondent | Tracey Ortiz GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L 9900 W. 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-20 |
Decision Date | 2016-08-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682119283 | K161706 | 000 |
00840682117883 | K161706 | 000 |