QEF · Class I · 21 CFR 876.2100

FDA Product Code QEF: Pressure Ulcer Management Tool

A Pressure Ulcer Management Tool Is A Prescription Device Intended For Patients At Risk Of Developing Pressure Ulcers. The Device Provides Output That Supports A User’s Decision To Increase Intervention. The Device Is An Adjunct Tool For Pressure Ulcer Management That Is Not Intended For Detection Or Diagnostic Purposes.

Leading manufacturers include Bruin Biometrics, LLC.

1
Total
0
Cleared
626d
Avg days
2018
Since

FDA 510(k) Cleared Pressure Ulcer Management Tool Devices (Product Code QEF)

1 devices
1–1 of 1
Not Cleared Dec 20, 2018
SEM Scanner (Model 200)
DEN170021
Bruin Biometrics, LLC
Gastroenterology & Urology · 626d

About Product Code QEF - Regulatory Context