The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Echopac.
Device ID | K072952 |
510k Number | K072952 |
Device Name: | GE ECHOPAC |
Classification | System, Image Processing, Radiological |
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 | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-18 |
Decision Date | 2007-11-16 |
Summary: | summary |