The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Hemostasis Management System Plus (hms Plus ), Model 305 Xx.
| Device ID | K101271 |
| 510k Number | K101271 |
| Device Name: | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX |
| Classification | Analyzer, Heparin, Automated |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Jeffrey L Koll |
| Correspondent | Jeffrey L Koll 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 | 2010-05-06 |
| Decision Date | 2010-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000158002 | K101271 | 000 |