The following data is part of a premarket notification filed by General Electric Co. with the FDA for Ge Voluson 730 Pro/expert Bt03 Ultrasound System.
Device ID | K032620 |
510k Number | K032620 |
Device Name: | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM |
Classification | System, Imaging, Pulsed Doppler, 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 | 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 | 2003-08-26 |
Decision Date | 2003-10-10 |
Summary: | summary |