The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Ge Logiq 700 With Coded Excitation Modification.
Device ID | K993364 |
510k Number | K993364 |
Device Name: | GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION |
Classification | System, Imaging, Pulsed Echo, 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 | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-06 |
Decision Date | 1999-11-05 |
Summary: | summary |