The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockertir Purge Control (apc) System.
| Device ID | K041558 |
| 510k Number | K041558 |
| Device Name: | STOCKERTIR PURGE CONTROL (APC) SYSTEM |
| Classification | Monitor And/or Control, Level Sensing, 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 | DTW |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-10 |
| Decision Date | 2004-07-02 |
| Summary: | summary |