510(k) K002159

SNORE SAT RECORDER, MODEL SS41 by Sagatech Electronics, Inc. — Product Code MNR

K002159 is an FDA 510(k) premarket notification submitted by Sagatech Electronics, Inc. for the device "SNORE SAT RECORDER, MODEL SS41". The FDA issued a decision of Substantially Equivalent on June 28, 2002. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375.