Scale, Patient

Device Code: 2605

Product Code(s): FRW

Device Classification Information

Device Type ID2605
Device NameScale, Patient
Regulation DescriptionPatient Scale.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.2720 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFRW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2605
DeviceScale, Patient
Product CodeFRW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPatient Scale.
CFR Regulation Number880.2720 [🔎]
Device Problems
Overheating Of Device
2
Calibration Problem
1
Loose Or Intermittent Connection
1
Device Maintenance Issue
1
Unintended Movement
1
Device Emits Odor
1
Device Inoperable
1
Material Integrity Problem
1
Device Operational Issue
1
Electrical /Electronic Property Problem
1
No Display / Image
1
Melted
1
Total Device Problems 13
TPLC Last Update: 2019-04-02 20:16:01

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