Chair, Ophthalmic, Ac-powered

Device Code: 4207

Product Code(s): HME

Device Classification Information

Device Type ID4207
Device NameChair, Ophthalmic, Ac-powered
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 CodeHME
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4207
DeviceChair, Ophthalmic, Ac-powered
Product CodeHME
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOphthalmic Chair.
CFR Regulation Number886.1140 [🔎]
Device Problems
Positioning Problem
1
Improper Or Incorrect Procedure Or Method
1
Use Of Device Problem
1
Total Device Problems 3
TPLC Last Update: 2019-04-02 20:44:46

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