The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Vscan Compact Diagnostic Ultrasound System.
| Device ID | K092756 |
| 510k Number | K092756 |
| Device Name: | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GE VINGMED ULTRASOUND AS STRANDPROMENADEN 45 Horten, NO N-3183 |
| Contact | Jan T Thollefsen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-09 |
| Decision Date | 2009-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115384 | K092756 | 000 |
| 00840682107853 | K092756 | 000 |