Name: Predicase
Price: 199 USD

K-number	K002499
Device name	BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
Applicant	Brentwood Medical Technology Corp.
Product code	BZG
Device class	Class II
Decision date	Nov 8, 2000
Decision	Substantially Equivalent
Regulation	868.1840

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Source

View the full FDA submission: accessdata.fda.gov

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BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

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