The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 5 Pro Or Expert.
Device ID | K032974 |
510k Number | K032974 |
Device Name: | GE LOGIQ 5 PRO OR EXPERT |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. 4855 WESTELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GENERAL ELECTRIC CO. 4855 WESTELECTRIC AVENUE PO BOX 414 Milwaukee, WI 53219 |
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 | 2003-09-24 |
Decision Date | 2003-10-21 |
Summary: | summary |