FDA.report

McKesson Cardiology ECG Management

Primary DI
80010939040028
Company
MCKESSON TECHNOLOGIES INC.
Model
14.0
Published
2017-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
962049362
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
80010939040028PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
80010939040028PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQKComputer, Diagnostic, Programmable2Cardiovascular870.1425NEligible

Premarket Submissions

SubmissionSupplement
K113515000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K113515000HORIZON CARDIOLOGY ECG MANAGEMENTMckesson Israel , Ltd.2012-03-16DQK

GMDN Terms

TermDefinition
Cardiac mapping system computerA dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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80010939010014McKesson Anesthesia Care15.22016-06-10
80010939040011McKesson Cardiology ECG Management13.2.12016-08-30
80010939050010McKesson Cardiology Hemo13.2.12016-08-30
80010939070018McKesson Cardiology™13.2.12016-08-30

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