Catalog Number

HC-PM10

Brand Name

HeartCheck Palm

Version/Model Number

HC-PM10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152863

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

d96f37af-5d2b-4ef8-bdf5-a30d29ed4c4c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-