The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Logiq P6.
Device ID | K073297 |
510k Number | K073297 |
Device Name: | GE LOGIQ P6 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa, WI 53226 |
Contact | Allen Schuh |
Correspondent | Allen Schuh GENERAL ELECTRIC CO. 9900 Innovation Drive Wauwatosa, WI 53226 |
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 | 2007-11-23 |
Decision Date | 2007-12-18 |
Summary: | summary |