The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq 500.
Device ID | K991611 |
510k Number | K991611 |
Device Name: | GE LOGIQ 500 |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GENERAL ELECTRIC CO. 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 | 1999-05-10 |
Decision Date | 1999-06-09 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682117357 | K991611 | 000 |