The following data is part of a premarket notification filed by Ge Medical Systems China Co., Ltd. with the FDA for Ge Venue 40, Model 5324338.
| Device ID | K091164 |
| 510k Number | K091164 |
| Device Name: | GE VENUE 40, MODEL 5324338 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS CHINA CO., LTD. NO. 19 CHANGJIANG ROAD NATIONAL HI-TECH DEV. ZONE Wuxi, Jiangsu Province, CN 214028 |
| Contact | Yalan Wu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-22 |
| Decision Date | 2009-05-05 |
| Summary: | summary |