Name: Predicase
Price: 199 USD

K-number	K022934
Device name	SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
Applicant	Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
Product code	BZD
Device class	Class II
Decision date	Nov 14, 2002
Decision	Substantially Equivalent
Regulation	868.5905

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Source

View the full FDA submission: accessdata.fda.gov

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SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650

Everything you need for a 510(k) submission. Nothing you don't.