The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert S3 Ups, Lvl Ctrl Bubb. Det., Dual Press. Ctrl., Temp Mont., Timer.
| Device ID | K955152 |
| 510k Number | K955152 |
| Device Name: | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER |
| Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | DTW |
| Subsequent Product Code | DTQ |
| Subsequent Product Code | KRL |
| CFR Regulation Number | 870.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1996-02-22 |