The following data is part of a premarket notification filed by Ge Medical Systems Israel, Ultrasound, Ltd. with the FDA for Modification To Ge Vivid S5 And S6 Diagnostic Ultrasound.
| Device ID | K092079 |
| 510k Number | K092079 |
| Device Name: | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | James T Turner |
| Correspondent | James T Turner GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| 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 | 2009-07-09 |
| Decision Date | 2009-08-06 |
| Summary: | summary |