510(k) K050309

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 by Viasys Medsystems — Product Code CAP

K050309 is an FDA 510(k) premarket notification submitted by Viasys Medsystems for the device "PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000". The FDA issued a decision of Substantially Equivalent on March 25, 2005. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Viasys Medsystems has at least 6 other 510(k) clearances on record.