The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for 3m Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion System.
Device ID | K950739 |
510k Number | K950739 |
Device Name: | 3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM |
Classification | Control, Pump Speed, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Martha Rumford |
Correspondent | Martha Rumford 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | DWA |
CFR Regulation Number | 870.4380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-17 |
Decision Date | 1995-11-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00886799000076 | K950739 | 000 |