FDA.reportPublic FDA data

SphygmoCor

Primary DI
19351315000017
Brand
SphygmoCor
Company
ATCOR MEDICAL PTY LTD
Model
CVMS
Device description
Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others].CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL:• CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)]• CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSKComputer, Blood-Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070795000
K080670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070795000SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.2007-08-31DSK
K080670000MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical2008-04-23DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19351315000024Direct MarkingGS10
19351315000017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1935131500002419351315000024
1935131500001719351315000017

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, multifunctionA small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751626706
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19351315000062CONNEQT PULSE BPM1AT2025-08-27
19351315000086CONNEQT PULSE BPM1AT2025-08-27
19351315000031SphygmoCorXCEL2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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