The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for Modification To Acuson Cv70 Cardiovascular System.
| Device ID | K050240 |
| 510k Number | K050240 |
| Device Name: | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 22010 S.E. 51ST STREET Issaquah, WA 98029 |
| Contact | Patrick 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 | 2005-02-02 |
| Decision Date | 2005-02-15 |
| Summary: | summary |