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510(k) Data Aggregation
K Number
K220028Device Name
NightOwl
Manufacturer
Ectosense nv
Date Cleared
2022-02-24
(50 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Ectosense nv
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
Device Description
The NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software"). The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement. The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode). The NightOwl Software signal processing algorithms produce a number of sleep and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
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K Number
K213463Device Name
NightOwl
Manufacturer
Ectosense nv
Date Cleared
2021-12-16
(50 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Ectosense nv
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea.
The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
Device Description
The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT).
The NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode)
- if the data is stored on the device, the data is retrieved when the NightOwl sensor . is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
- If the device is used in Streaming mode, the data is stored by the Ectosense app . on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
- The NightOwl Software signal processing algorithms produce a number of sleep . and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
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K Number
K191031Device Name
NightOwl
Manufacturer
Ectosense nv
Date Cleared
2020-03-06
(323 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Ectosense nv
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea.
The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).
Device Description
The Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor is a small biocompatible enclosure with a sensor window made from PMMA (bottom part) and ABS (top part). The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode).
If the data is stored on the device, the data is retrieved when the NightOwl sensor is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
If the device is used in Streaming mode, the data is stored by the Ectosense app on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
The NightOwl Software signal processing algorithms produce a number of sleep and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
Ask a Question
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