The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Microtec Bacterial Filter.
Device ID | K790407 |
510k Number | K790407 |
Device Name: | MICROTEC BACTERIAL FILTER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MEDEX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-26 |
Decision Date | 1979-05-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50351688505031 | K790407 | 000 |