The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockert Centrifugal Pump Console.
Device ID | K020571 |
510k Number | K020571 |
Device Name: | STOCKERT CENTRIFUGAL PUMP CONSOLE |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro, MA 02760 |
Contact | Cynthia J.m. Nolte |
Correspondent | Cynthia J.m. Nolte STOCKERT INSTRUMENTE GMBH 49 PLAIN ST. North Attleboro, MA 02760 |
Product Code | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-21 |
Decision Date | 2002-09-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04033817901495 | K020571 | 000 |
04033817901020 | K020571 | 000 |
04033817901013 | K020571 | 000 |
04033817900641 | K020571 | 000 |
04033817900542 | K020571 | 000 |