FDA.reportPublic FDA data

Actiheart

Primary DI
B329AH556
Brand
Actiheart
Company
CAMNTECH LIMITED
Model
AH5
Catalog number
18-500
Device description
Ambulatory ECG recorder with acclerometer - single channel
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWKConditioner, Signal, Physiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWKConditioner, Signal, PhysiologicalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052489000ACTIHEARTRespironics, Inc.2005-09-27GWK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B329AH556PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Telemetric electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 830-755-8036sales@camntech.com

Regulatory Flags#

DUNS number
399114941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B329AH420ActiheartAH408-3052016-09-24
B329AWV01E22Actiwave1E08-5142016-09-24
B329AWV02E25Actiwave2E08-5212016-09-24
B329AWV02M25Actiwave2M08-5362016-09-24
B329AWV04E22Actiwave4E08-5572016-09-24
B329AWVC23ActiwaveCardio08-6032016-09-24
B329AWVM33ActiwaveMotion08-5652016-09-24
B329PDV25PRO-DiaryPDV05-1212019-08-29
B329MW850MotionWatchMW804-1112016-09-24
B329MWR50MotionWatchMW-R04-1212018-11-02
B329PDM25PRO-DiaryPDM05-1112016-09-24
B329AHBT56ActiheartAH5 BT18-5052019-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814901021541Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2025-02-14
00814901021527Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2023-12-04
00814901021534Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2023-12-04
00814901021473NeuroPlex E128BLACKROCK MICROSYSTEMS, LLCGWK2023-05-18
00814901021480NeuroPlex E128 SterileBLACKROCK MICROSYSTEMS, LLCGWK2023-05-18
00814901021435Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2022-09-20
00814901021442Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2022-09-20
00814901021411Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-11-24
00814901021343Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021350Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021367Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021374Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021381Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021398Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
00814901021404Digital NeuroPort Biopotential Signal Processing SystemBLACKROCK MICROSYSTEMS, LLCGWK2021-07-01
B329AHBT56ActiheartCAMNTECH LIMITEDGWK2019-08-29
00850154007079MORPHEUSBLACKROCK NEUROMED, LLCGWK2016-12-07
00850154007024CERVELLO 32 WBLACKROCK NEUROMED, LLCGWK2016-12-06
00850154007031CERVELLO 64 WBLACKROCK NEUROMED, LLCGWK2016-12-06
00850154007048JB CERVELLO 32BLACKROCK NEUROMED, LLCGWK2016-12-06
00850154007055JB CERVELLO 64BLACKROCK NEUROMED, LLCGWK2016-12-06
00850154007086CERVELLO SOFTWAREBLACKROCK NEUROMED, LLCGWK2016-12-06
00850154007017CERVELLO 64BLACKROCK NEUROMED, LLCGWK2016-12-05
B329AH420ActiheartCAMNTECH LIMITEDGWK2016-09-24
00606959021006ActicalRespironics, Inc.GWK2016-09-19
00850154007000CERVELLO 32BLACKROCK NEUROMED, LLCGWK2016-07-15