510(k) K894689

PENLON IDP PRESSURE FAILURE ALARM by Penlon, Inc. — Product Code CAP

K894689 is an FDA 510(k) premarket notification submitted by Penlon, Inc. for the device "PENLON IDP PRESSURE FAILURE ALARM". The FDA issued a decision of Substantially Equivalent on August 10, 1989. 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. Penlon, Inc. has at least 10 other 510(k) clearances on record.