510(k) K001430

RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 by Vortran Medical Technology 1, Inc. — Product Code BTL

K001430 is an FDA 510(k) premarket notification submitted by Vortran Medical Technology 1, Inc. for the device "RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000". The FDA issued a decision of Substantially Equivalent on July 5, 2000. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Vortran Medical Technology 1, Inc. has at least 10 other 510(k) clearances on record.