510(k) K894361

LIFECARE PRESSURE ALARM CAT. NO. 34-010 by Lifecare Services, Inc. — Product Code CAP

K894361 is an FDA 510(k) premarket notification submitted by Lifecare Services, Inc. for the device "LIFECARE PRESSURE ALARM CAT. NO. 34-010". The FDA issued a decision of Substantially Equivalent on October 5, 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. Lifecare Services, Inc. has at least 10 other 510(k) clearances on record.