The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Logiq S8.
Device ID | K111582 |
510k Number | K111582 |
Device Name: | LOGIQ S8 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GE HEALTHCARE 9900 INNOVATION DRIVE MAIL STOP RP-2138 Wauwatosa, WI 53226 |
Contact | Bryan Behn |
Correspondent | Bryan Behn GE HEALTHCARE 9900 INNOVATION DRIVE MAIL STOP RP-2138 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 | 2011-06-06 |
Decision Date | 2011-07-26 |
Summary: | summary |