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510(k) Data Aggregation
K Number
K243216Device Name
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
Manufacturer
Analog Devices
Date Cleared
2024-12-10
(68 days)
Product Code
MWI, BZQ, DPS, DQD, DSB, DXH, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Analog Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADI Sensinel CPM (Cardiopulmonary Management) System is a wireless remote monitoring system intended for use by healthcare professionals for spot checking of physiological data in home and healthcare settings. This can include:
• ECG
- · Heart Auscultation Sounds
- · Skin Temperature
- · Thoracic Impedance (including Changes in Thoracic Impedance)
- · Respiration Rate and relative changes in Tidal Volume
· Heart Rate
- Diastolic Heart Sounds Strength
- · Body Posture (including Tilt Angle)
Data are transmitted wirelessly from the ADI CPM (Cardiopulmonary Management) Wearable and Base Station for storage and analysis. The device is intended for use on general care adult patients who are 18 years of age or older to provide physiological information. The data from the ADI CPM (Cardiopulmonary Management) System Platform are intended for use by healthcare professional as an aid to diagnosis and treatment.
The ADI CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot checking and does not have continuous monitoring capability. The device does not produce alarms and is not intended for active patient monitoring (real-time).
The ADI CPM System in contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
Device Description
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K Number
K231086Device Name
CPM System
Manufacturer
Analog Devices, Inc.
Date Cleared
2023-12-22
(249 days)
Product Code
MWI, BZQ, DPS, DQD, DSB, DXH, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Analog Devices, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sensinel™ CPM System is a wireless remote monitoring system intended for use by healthcare professionals for spot-checking of physiological data in home and healthcare settings. This can include:
- ECG
- Heart Auscultation Sounds
- Skin Temperature (Obtained from left chest area)
- Thoracic Impedance (including changes in Thoracic Impedance)
- Respiration Rate and relative changes in Tidal Volume
- Heart Rate
- Diastolic Heart Sounds Strength
- Body Posture (including Tilt Angle)
Data are transmitted wirelessly from the Sensinel™ CPM Wearable and Base Station for storage and analysis. The CPM Wearable is intended for use on general care adult patients 18 years of age or older to provide physiological information. The data from the CPM System is intended for use by healthcare professionals as an aid to diagnosis and treatment.
The CPM System is intended to be used by patients at rest and not performing any activities or movements. This system is for spot-checking and does not have continuous monitoring capability. The CPM Wearable does not produce alarms and is not intended for active patient monitoring (in real-time).
The Sensinel™ CPM System is contraindicated for those patients with life threatening arrhythmias requiring immediate medical intervention.
Device Description
Not Found
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