510(k) K901028

ENVIRONMENTAL CONTROL UNIT MODEL 7000 by Baylor Biomedical Services — Product Code IQA

K901028 is an FDA 510(k) premarket notification submitted by Baylor Biomedical Services for the device "ENVIRONMENTAL CONTROL UNIT MODEL 7000". The FDA issued a decision of Substantially Equivalent on March 13, 1990. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Baylor Biomedical Services has at least 3 other 510(k) clearances on record.