The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Stockert 1/4 Bubble Sensor.
Device ID | K925541 |
510k Number | K925541 |
Device Name: | STOCKERT 1/4 BUBBLE SENSOR |
Classification | Detector, Bubble, Cardiopulmonary Bypass |
Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Contact | David Taylor |
Correspondent | David Taylor SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine, CA 92713 |
Product Code | KRL |
CFR Regulation Number | 870.4205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-03 |
Decision Date | 1993-02-02 |