510(k) K963177

TED 191 by Teledyne Brown Engineering — Product Code CCL

K963177 is an FDA 510(k) premarket notification submitted by Teledyne Brown Engineering for the device "TED 191". The FDA issued a decision of Substantially Equivalent on November 13, 1997. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Teledyne Brown Engineering has at least 1 other 510(k) clearance on record.