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510(k) Data Aggregation
K Number
K220893Device Name
Strados Remote Electronic Stethoscope Platform (RESP)
Manufacturer
Strados Labs, Inc.
Date Cleared
2022-04-27
(30 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
Strados Labs, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Device Description
The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient. The Strados Remote Electronic Stethoscope Platform (RESP) is comprised of the Strados Wearable Device (SWD), Strados Charging Station (SCS) and external power supply, and Strados Patient Adhesive (SPA) used to adhere the SWD to the patient. The SWD is controlled by a mobile device running the Strados Mobile Application (SMA) via Bluetooth connection. The Strados Wearable Device (SWD) sits on the chest wall and passively records the patient's airway sounds, including but not limited to cough, wheeze, rhonchi, rales, crackles, coarse (bronchial) breath sounds, quiet breathing, and chest wall movement onto internal memory. The Strados Mobile App (SMA) on a smartphone allows playback of lung sounds from the wearable device in order for clinicians to listen to the patient's lung sounds. The device is used in a healthcare and outpatient setting including the home.
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