The following data is part of a premarket notification filed by Ge Medical Systems Israel Ltd. with the FDA for Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System.
Device ID | K142323 |
510k Number | K142323 |
Device Name: | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GE MEDICAL SYSTEMS ISRAEL LTD. 4 Etgar Street Tirat Carmel, IL 39120 |
Contact | Bryan Behn |
Correspondent | Bryan Behn GE Healthcare 9900 Innovation Drive 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 | 2014-08-20 |
Decision Date | 2014-10-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682120128 | K142323 | 000 |
00840682115650 | K142323 | 000 |
00840682115582 | K142323 | 000 |
00840682111966 | K142323 | 000 |
00840682110976 | K142323 | 000 |
00840682105316 | K142323 | 000 |