Adaptometer (biophotometer)

Device Code: 4159

Product Code(s): HJW

Device Classification Information

Device Type ID4159
Device NameAdaptometer (biophotometer)
Regulation DescriptionAdaptometer (biophotometer).
Regulation Medical SpecialtyOphthalmic
Review PanelOphthalmic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED)
Diagnostic And Surgical Devices Branch (DSDB)
Submission Type510(K) Exempt
CFR Regulation Number886.1050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHJW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4159
DeviceAdaptometer (biophotometer)
Product CodeHJW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAdaptometer (biophotometer).
CFR Regulation Number886.1050 [🔎]
TPLC Last Update: 2019-04-02 20:43:58

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