Product Code: QLM
FDA not classified
Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
Unknown
The Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool is a not-classified device intended for use by healthcare providers in the ICU for adult patients for the computation of patient status indices as an adjunct to patient monitoring, authorized during the declared COVID-19 public health emergency to support critical care decision-making. The product code is QLM, reviewed by the Cardiovascular panel, with no regulation number assigned. The device is not an implant and is not flagged as life-sustaining.
510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active
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Basic Information
- Product Code
- QLM
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 8
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
Unclassified Reason
11