The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Aeps.
Device ID | K842054 |
510k Number | K842054 |
Device Name: | COBE AEPS |
Classification | Detector, Bubble, Cardiopulmonary Bypass |
Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRL |
CFR Regulation Number | 870.4205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-22 |
Decision Date | 1984-08-02 |