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 |