510(k) K894850

8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI by Modern Engineering Co., Inc. — Product Code CAN

K894850 is an FDA 510(k) premarket notification submitted by Modern Engineering Co., Inc. for the device "8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI". The FDA issued a decision of Substantially Equivalent on August 31, 1989. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Modern Engineering Co., Inc. has at least 1 other 510(k) clearance on record.