FDA.reportPublic FDA data

PalmScan PM2000

Primary DI
00853569007115
Brand
PalmScan PM2000
Company
Micro Medical Devices, Inc.
Model
PM2000
Catalog number
900-0011-12
Device description
Advanced VR Pupilometer PUPILLOGRAPH
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRIPupillograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRIPupillographOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853569007115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853569007115008535690071158535690071150853569007115

GMDN Terms#

Term, Definition table
TermDefinition
PupillographA mains electricity (AC-powered) graphic recorder used for recording the response of the pupil to reflected light. It is used for ophthalmic diagnostic purposes.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8182223310info@micromedinc.com

Regulatory Flags#

DUNS number
146767400
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853569007009PalmScan A2000 Pro with IOL CalculatorA2000900-0006-02-22024-01-16
00853569007016PalmScan P2000P2000900-0006-02-32023-08-16
00853569007023PalmScan P2000FPP2000FP900-0005-012023-08-16
00853569007030PalmScan AP2000AP2000900-0006-02-12023-08-16
00853569007047PalmScan K2000K2000900-0008-012023-08-16
00853569007108PalmScan VF2000VF2000 900-0015-012023-08-16
00853569007122PalmScan DA2000DA2000900-0011-102023-08-16
00853569007146PalmScan VS2000VS2000900-0011-022023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010709719Virtual Eye PROVirtual Vision HealthHRI2024-12-16
00860010709726Virtual Eye ELITE SVirtual Vision HealthHRI2024-12-16
00860010709795Virtual Eye SoftwareVirtual Vision HealthHRI2024-12-16
00860010709788Virtual Eye SoftwareVirtual Vision HealthHRI2024-11-27
00860010709757Virtual Eye SoftwareVirtual Vision HealthHRI2024-08-20
00860010709740Virtual Eye SoftwareVirtual Vision HealthHRI2024-05-07
00860010709733Virtual Eye SoftwareVirtual Vision HealthHRI2024-02-27
00860001720402Virtual FieldVirtual Field, Inc.HRI2023-01-23
00860001720419Virtual FieldVirtual Field, Inc.HRI2023-01-23
04582275270051N/AKONAN MEDICAL USA, INC.HRI2019-09-09