Duns Number:128639556
Device Description: The CNMC Model 206 is a medical dosimeter, or medical electrometer that is capable of perf 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.
Catalog Number
206
Brand Name
206 Electrometer
Version/Model Number
206
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 07, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150265
Product Code
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
c93952f7-7e2f-4304-8914-52645126dc9b
Public Version Date
August 16, 2021
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |