The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 9, Models 2188900, 2375600, 2404587 And 5150000.
Device ID | K061129 |
510k Number | K061129 |
Device Name: | GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. 99000 INNOVATION DRIVE Wauwatosa, WI 53226 |
Contact | Patricia Taige |
Correspondent | Patricia Taige GENERAL ELECTRIC CO. 99000 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-04-24 |
Decision Date | 2006-06-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682117968 | K061129 | 000 |
00840682117289 | K061129 | 000 |
00840682117272 | K061129 | 000 |
00840682117227 | K061129 | 000 |
00840682107655 | K061129 | 000 |