ER920 Braemar - ENHANCED ALGORITHM ECG EVENT - BRAEMAR MANUFACTURING, LLC

Duns Number:049529118

Device Description: ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai ENHANCED ALGORITHM ECG EVENT RECORDERhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1058652#

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More Product Details

Catalog Number

-

Brand Name

ER920 Braemar

Version/Model Number

900-0557-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071011

Product Code Details

Product Code

MWJ

Product Code Name

Electrocardiograph,Ambulatory(Without Analysis)

Device Record Status

Public Device Record Key

16b5e089-188c-4c6c-89e9-9d2b326213f3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRAEMAR MANUFACTURING, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 122