The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Sonoline G50 And G60 S Diagnostic Ultrasound Systems.
| Device ID | K040060 |
| 510k Number | K040060 |
| Device Name: | SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 22010 S.E. 51ST ST. Issaquah, WA 98029 -7298 |
| Contact | Patrick J Lynch |
| 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 | 2004-01-13 |
| Decision Date | 2004-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005010 | K040060 | 000 |
| 04056869004563 | K040060 | 000 |
| 04056869003672 | K040060 | 000 |