The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Heparin Dose Response Controls, Model 306-20 Por.
Device ID | K051040 |
510k Number | K051040 |
Device Name: | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
Classification | Analyzer, Heparin, Automated |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Bruce Backlund |
Correspondent | Bruce Backlund MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Product Code | JOX |
CFR Regulation Number | 864.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-25 |
Decision Date | 2005-05-24 |
Summary: | summary |