K-number	K000648
Device name	SPIRO PRO
Applicant	Erich Jaeger GmbH
Product code	BTY
Device class	Class II
Decision date	Mar 29, 2000
Decision	Substantially Equivalent
Regulation	868.1890

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Source

View the full FDA submission: accessdata.fda.gov

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SPIRO PRO

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