SNAP DIAGNOSTICS

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilatory Effort Recorder (MNR) (2)

Premarket Exempt

Clear

Model 7 - B577710000 Catalog Number :

Device Description : The SNAP Model 7 is a 6 channel data recorder that records respiratory and oxime The SNAP Model 7 is a 6 channel data recorder that records respiratory and oximetry data. A canula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position.

Device Class : 2

Duns Number: 827445854

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

Model 8 - B577810000 Catalog Number :

Device Description : The SNAP Model 8 is an at home sleep recorder with five data channels that recor The SNAP Model 8 is an at home sleep recorder with five data channels that records respiratory and oximetry data. A nasal/oral cannula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position.