The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Logiq 9 Model 2375600.
Device ID | K030934 |
510k Number | K030934 |
Device Name: | GE LOGIQ 9 MODEL 2375600 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
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 | 2003-03-25 |
Decision Date | 2003-04-17 |
Summary: | summary |