FDA.reportPublic FDA data

CloudHRV™ System

Primary DI
G697684810
Brand
CloudHRV™ System
Company
Inmedix, Inc.
Model
68481
Catalog number
68481
Device description
This previous DI number, Version Number, and Catalog number were updated to current DI number G697100010010, Model number 10001001, and Catalog number 10001001 as of 2026-01-30. There was no other change to the device itself.
Published
2025-02-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241217000CloudHRV™ System (100-01-001)Inmedix, Inc.2025-01-16DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G697684810PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117788373
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G697100010010CloudHRV™ System10001001100010012026-01-30

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Primary DI, Brand, Company table
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