510(k) K081778

NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS by Instrumentation Industries, Inc. — Product Code CAP

K081778 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS". The FDA issued a decision of Substantially Equivalent on September 12, 2008. 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. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.