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 |