510(k) K242424

Bluebird Single-Use Respiratory Effort Belt by Cadwell Industries, Inc. — Product Code MNR

K242424 is an FDA 510(k) premarket notification submitted by Cadwell Industries, Inc. for the device "Bluebird Single-Use Respiratory Effort Belt". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375. Cadwell Industries, Inc. has at least 10 other 510(k) clearances on record.