510(k) K202018

Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation by Hill-Rom, Inc. — Product Code BZQ

K202018 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation". The FDA issued a decision of Substantially Equivalent on March 4, 2021. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.