The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Monitor Kits, Blood Level.
Device ID | K781145 |
510k Number | K781145 |
Device Name: | MONITOR KITS, BLOOD LEVEL |
Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTW |
CFR Regulation Number | 870.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-10 |
Decision Date | 1978-07-27 |