The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Cypress System.
| Device ID | K010950 |
| 510k Number | K010950 |
| Device Name: | CYPRESS SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ACUSON CORP. 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein ACUSON CORP. 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-06-27 |