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510(k) Data Aggregation
K Number
K182543Device Name
Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Manufacturer
snap40 Ltd
Date Cleared
2018-11-14
(58 days)
Product Code
MSX, BZQ, DQA, DRG, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
snap40 Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
snap40 is intended for reusable bedside, mobile and central multi-parameter, continuous and intermittent physiologic patient monitoring of adult patients in environments where patient care is provided by trained healthcare professionals.
snap40 is intended to provide visual and audible physiologic multi-parameter alarms.
snap40 is intended for temperature monitoring temperature at the upper arm is clinically indicated.
snap40 continuously monitors the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- · Movement
snap40 is intended for intermittent or spot-check monitoring of respiration rate.
snap40 is not intended for use in high-acuity environments, such as ICU or operating rooms or for use in the home
snap40 is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. snap40 is not a substitute for an ECG monitor.
snap40 is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
Device Description
snap40 consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station.
snap40 is intended to continuously monitor adult patient vital signs in non-critical areas of the hospital, mainly general medical/surgical units, across pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). snap40 is intended for intermittent or spot-checking monitoring of respiration rate (RESP).
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