The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Microbar Monitoring Line Filter.
Device ID | K792510 |
510k Number | K792510 |
Device Name: | MICROBAR MONITORING LINE FILTER |
Classification | Filter, Infusion Line |
Applicant | MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-05 |
Decision Date | 1979-12-20 |