SEER 1000 Apple App 2067634-056

GUDID 04250903201202

The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data).

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder
Primary Device ID04250903201202
NIH Device Record Key9b1a1559-8381-4733-9987-8f0feb2b8f48
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEER 1000 Apple App
Version Model NumberV1.2.1
Catalog Number2067634-056
Company DUNS331682898
Company Namegetemed Medizin- und Informationstechnik AG
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49332939420
Emailinfo@getemed.de

Device Identifiers

Device Issuing AgencyDevice ID
GS104250903201202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWJElectrocardiograph,Ambulatory(Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-21

Devices Manufactured by getemed Medizin- und Informationstechnik AG

04250903202636 - SEER 10002023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903202643 - SEER 10002023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903202650 - SEER 10002023-12-11 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903202520 - CardioDay 2023-07-31 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator
04250903200724 - SEER 10002021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903200731 - SEER 10002021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903200748 - SEER 10002021-06-25 The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by
04250903202469 - CardioDay 2021-06-03 The CardioDay Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulator

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