Name: Predicase
Price: 199 USD

K-number	K162014
Device name	Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
Applicant	Bluepoint Medical GmbH & Co. KG
Product code	DQA
Device class	Class II
Decision date	Feb 6, 2017
Decision	Substantially Equivalent
Regulation	870.2700

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Source

View the full FDA submission: accessdata.fda.gov

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Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

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