The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Centrifugal Pump.
Device ID | K011838 |
510k Number | K011838 |
Device Name: | CENTRIFUGAL PUMP |
Classification | Control, Pump Speed, Cardiopulmonary Bypass |
Applicant | STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Rosina Robinson |
Correspondent | Rosina Robinson STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | DWA |
CFR Regulation Number | 870.4380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-12 |
Decision Date | 2002-02-05 |
Summary: | summary |