Chair, Ophthalmic, Manual

Device Code: 4206

Product Code(s): HMD

Device Classification Information

Device Type ID4206
Device NameChair, Ophthalmic, Manual
Regulation DescriptionOphthalmic Chair.
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 Number886.1140 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeHMD
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4206
DeviceChair, Ophthalmic, Manual
Product CodeHMD
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Chair.
CFR Regulation Number886.1140 [🔎]
Device Problems
Defective Component
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:44:45

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