The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for S3 Cyclic Rpm Control.
Device ID | K971520 |
510k Number | K971520 |
Device Name: | S3 CYCLIC RPM CONTROL |
Classification | Pump, Blood, Cardiopulmonary Bypass, Roller Type |
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 | DWB |
CFR Regulation Number | 870.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-25 |
Decision Date | 1997-09-10 |
Summary: | summary |