The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Hemostasis Managment System Plus (hms-plus).
Device ID | K111339 |
510k Number | K111339 |
Device Name: | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) |
Classification | Analyzer, Heparin, Automated |
Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Contact | Amra Racic |
Correspondent | Amra Racic MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Product Code | JOX |
CFR Regulation Number | 864.5680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-05-12 |
Decision Date | 2011-06-08 |
Summary: | summary |