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 |