K-number	K243216
Device name	Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
Applicant	Analog Devices
Product code	MWI
Device class	Class II
Decision date	Dec 10, 2024
Decision	Substantially Equivalent
Regulation	870.2300

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Sensinel Cardiopulmonary Management (CPM) System is a wireless remote monitoring device for healthcare professionals to perform spot checks of physiological data in home and healthcare settings. It measures ECG, heart auscultation sounds, skin temperature, thoracic impedance, respiration rate, heart rate, diastolic heart sounds strength, and body posture. Data transmits wirelessly from a wearable device and base station for storage and analysis to aid diagnosis and treatment in general care adult patients 18 years or older.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)

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