SEER 1000 2067634-068

GUDID 04250903201011

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional.

getemed Medizin- und Informationstechnik AG

Electrocardiographic ambulatory recorder
Primary Device ID04250903201011
NIH Device Record Key9f920b33-9211-4f58-82db-609deb71bdca
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEER 1000
Version Model Number48 Hour - Korean
Catalog Number2067634-068
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250903201011 [Primary]

FDA Product Code

MWJElectrocardiograph, Ambulatory (Without Analysis)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-24
Device Publish Date2025-03-14

On-Brand Devices [SEER 1000]

04250903200748The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200731The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200724The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903202650The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903202643The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903202636The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903201127The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903201103The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903201080The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200915The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200892The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200878The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903201035The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903201011The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000
04250903200991The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.