Impulse 6000D - Defibrillator Analyzer - FLUKE ELECTRONICS CORPORATION

Duns Number:002687614

Device Description: Defibrillator Analyzer

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More Product Details

Catalog Number

2811928

Brand Name

Impulse 6000D

Version/Model Number

IMPULSE 6000D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K072114

Product Code Details

Product Code

DRL

Product Code Name

Tester, Defibrillator

Device Record Status

Public Device Record Key

a5e436a3-0694-4aef-baed-0f472d5b4814

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLUKE ELECTRONICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21