The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Siii Alarm Amplifier.
| Device ID | K011088 |
| 510k Number | K011088 |
| Device Name: | SIII ALARM AMPLIFIER |
| Classification | Console, Heart-lung Machine, 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 | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-10 |
| Decision Date | 2001-05-02 |