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— 510(k) K202018

Name: FDA 510(k) clearance K202018
Creator: U.S. Food and Drug Administration
Published: 2021-03-04

Substantially Equivalent

Hill-Rom, Inc.

FDA 510(k) clearance K202018 for 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, Substantially Equivalent on 2021-03-04. Applicant: Hill-Rom, Inc.. Device class: 2.

Clearance details

Applicant: Hill-Rom, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2020-07-21
Decision date: 2021-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Batesville, IN, US

Download summary PDF View on FDA.gov ↗

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