The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert S3 Roller Pump Module Stockert S3 Console.
| Device ID | K950990 |
| 510k Number | K950990 |
| Device Name: | STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Diane Minear |
| Correspondent | Diane Minear STOECKERT INSTRUMENTE 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 | 1995-03-03 |
| Decision Date | 1996-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817901150 | K950990 | 000 |