DeviceClearance

VitalFlow Console— 510(k) K230364

Substantially Equivalent

Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)

FDA 510(k) clearance K230364 for VitalFlow Console, Substantially Equivalent on 2023-08-25. Applicant: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). Device class: 2.

Clearance details

Applicant
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.)
Product code
Code QNR
Device class
Class 2
Regulation
21 CFR 870.4100
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dexter, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code QNR

view all

Adverse events under product code QNR

product code QNR
Death
11
Total
11

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K230364

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230364.

Data sourced from openFDA. This site is unofficial and independent of the FDA.