The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert Compact System Version 2.0.
| Device ID | K002118 |
| 510k Number | K002118 |
| Device Name: | STOCKERT COMPACT SYSTEM VERSION 2.0 |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J. M. Nolte |
| Correspondent | Cynthia J. M. Nolte STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-13 |
| Decision Date | 2000-08-09 |