← FDA Medical Device Classifications

Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool

QLM · Not classified · Unknown

Classification

FDA Product Code
QLM
Device class
Not classified
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the declared public health emergency.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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