K-number	K101022
Device name	PULMOTRACK 5050 WHOLTER, MODEL 5050
Applicant	Karmelsonix
Product code	DSH
Device class	Class II
Decision date	Jul 9, 2010
Decision	Substantially Equivalent
Regulation	870.2800

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View the full FDA submission: accessdata.fda.gov

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PULMOTRACK 5050 WHOLTER, MODEL 5050

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