ECG App

GUDID 00190198909541

APPLE INC.

Cardiac electrophysiology application software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software Cardiac electrophysiology processing software
Primary Device ID00190198909541
NIH Device Record Key44bd3e74-b8f9-4d96-9e1f-0019810de75b
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG App
Version Model NumberFeature Version 1.x
Company DUNS060704780
Company NameAPPLE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100190198909541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDAElectrocardiograph Software For Over-The-Counter Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-14
Device Publish Date2019-01-14

On-Brand Devices [ECG App]

00190198909541Feature Version 1.x
00190198909534Feature Version 1.x

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.