The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Bicarbonate Module, Bcm-10.
Device ID | K810127 |
510k Number | K810127 |
Device Name: | GAMBRO BICARBONATE MODULE, BCM-10 |
Classification | Subsystem, Proportioning |
Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKR |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-19 |
Decision Date | 1981-02-25 |