The following data is part of a premarket notification filed by General Electric Co. with the FDA for Logiqbook.
Device ID | K014206 |
510k Number | K014206 |
Device Name: | LOGIQBOOK |
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 | 2001-12-21 |
Decision Date | 2002-01-16 |
Summary: | summary |