VitalFlow Console
Summary
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) received 510(k) clearance for VitalFlow Console, a QNR device. Cleared on 2023-08-25.
Details
Source
510(k) Clearance
External ID
K230364
Action Date
2023-08-25
Status
Traditional
Category
device
Product Code
QNR
Product Description
VitalFlow Console. Product code: QNR.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 389 device clearances issued this month. Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) has received 2 total clearances in our database.
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) have FDA actions?
Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.) has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230364" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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