The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Sonoline 4xx.
| Device ID | K946179 |
| 510k Number | K946179 |
| Device Name: | SIEMENS SONOLINE 4XX |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 22010 S.E. 51ST ST. Issaquah, WA 98027 -7002 |
| Contact | Steve Hesler |
| Correspondent | Steve Hesler SIEMENS MEDICAL SOLUTIONS USA, INC. 22010 S.E. 51ST ST. Issaquah, WA 98027 -7002 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-19 |
| Decision Date | 1995-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869004556 | K946179 | 000 |
| 04056869004532 | K946179 | 000 |
| 04056869004419 | K946179 | 000 |
| 04056869003887 | K946179 | 000 |
| 04056869003870 | K946179 | 000 |