Name: Predicase
Price: 199 USD

K-number	K972203
Device name	BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT
Applicant	Allied Healthcare Products, Inc.
Product code	CBK
Device class	Class II
Decision date	Nov 6, 1997
Decision	Substantially Equivalent - Subject to Tracking Reg.
Regulation	868.5895

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View the full FDA submission: accessdata.fda.gov

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BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER, VOLUME VENTILATOR WITH PRESSURE LIMIT

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