The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Saturation/hematocrit Monitor System.
Device ID | K910421 |
510k Number | K910421 |
Device Name: | SATURATION/HEMATOCRIT MONITOR SYSTEM |
Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
Applicant | MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Norma Lowe |
Correspondent | Norma Lowe MEDTRONIC VASCULAR 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | DRY |
CFR Regulation Number | 870.4330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-30 |
Decision Date | 1991-10-15 |