AMA Optics Brightness Acuity Meter BAM01

GUDID G506BAM010

A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.

AMA Optics, Inc.

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Primary Device IDG506BAM010
NIH Device Record Keydfe46e33-a265-4fc0-a970-514f69ffce13
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMA Optics Brightness Acuity Meter
Version Model NumberGLARE-01-DEUCE
Catalog NumberBAM01
Company DUNS192827462
Company NameAMA Optics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG506BAM010 [Primary]

FDA Product Code

HOXChart, Visual Acuity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by AMA Optics, Inc.

G506NC010 - NeuroColor2023-10-09 An ophthalmic device that consists of various coloured materials, e.g., coloured yarns or colour vision plates (multicoloured pl
G506BAM010 - AMA Optics Brightness Acuity Meter2023-09-11A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
G506BAM010 - AMA Optics Brightness Acuity Meter2023-09-11 A hand-held device that illuminates the eye while viewing a visual acuity chart for measuring the presence and degree of glare.
G506MACDX010 - MacDx2023-09-11 MacDx Dark Adaptometer is a device to measure dark adaptation of the retina.
G506PH010 - AMA Optics Panoramic Pinhole2023-09-11 An individual ophthalmic lens from a trial lens set having multiple pinholes separate by clear plastic.
G506PHLC010 - AMA Optics Pinhole Clip2023-09-11 A lens chip having an optical lens and a pinhole disc with multiple apertures.
G506PHLC020 - RAM Panoramic Pinhole Clip2023-09-11 A lens clip having an optical lens and a pinhole disc with multiple apertures, each surrounded by an opaque halo.
G506RAM030 - AMA Optics Retinometer2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture
G506RAM040 - AMA Optics Retinometer2023-09-11 An ophthalmic retro-illuminated chart with adjustable brightness that is printed with various symbols (letters, numbers, picture

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