The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Heptrac Electronic Quality Control.
| Device ID | K981815 |
| 510k Number | K981815 |
| Device Name: | HEPTRAC ELECTRONIC QUALITY CONTROL |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Contact | Joyce Thomas |
| Correspondent | Joyce Thomas MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-22 |
| Decision Date | 1998-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994615633 | K981815 | 000 |
| 00763000014902 | K981815 | 000 |