510(k) K000712

PORTABLE INTENSIVE CARE UNIT, MODEL PIC by Medical Research Laboratories, Inc. — Product Code CCK

K000712 is an FDA 510(k) premarket notification submitted by Medical Research Laboratories, Inc. for the device "PORTABLE INTENSIVE CARE UNIT, MODEL PIC". The FDA issued a decision of Substantially Equivalent on April 27, 2000. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Medical Research Laboratories, Inc. has at least 10 other 510(k) clearances on record.