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 |