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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688505000 | K792510 | 000 |