510(k) K953491

HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE by Gibeck, Inc. — Product Code BYD

K953491 is an FDA 510(k) premarket notification submitted by Gibeck, Inc. for the device "HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE". The FDA issued a decision of Substantially Equivalent on August 25, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Gibeck, Inc. has at least 10 other 510(k) clearances on record.