FDA.reportPublic FDA data

206 Electrometer

Primary DI
00862246000301
Brand
206 Electrometer
Company
CNMC CO., INC.
Model
206
Catalog number
206
Device description
The CNMC Model 206 is a medical dosimeter or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected.
Published
2020-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150265000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150265000Model 206 Electrometer/DosimeterCnmc Company Incorporated2015-09-03IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08622460003012PreviousGS10
00862246000301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
08622460003012086224600030128622460003012
00862246000301008622460003018622460003010862246000301

GMDN Terms#

Term, Definition table
TermDefinition
Radiation electrometerA stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
128639556
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08622460003012206 Electrometer2062062016-09-20
00860321001410Water Phantoms with Depth Positioning AssemblyWP-3840WP-38402018-08-27
00860321001403Water Phantoms with Depth Positioning AssemblyWP-3040 / WP-3840WP-30402018-08-16

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Primary DI, Brand, Company table
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