Cleared Traditional

Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation

K180079 · Hill-Rom, Inc. · Anesthesiology
May 2018
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K180079 is an FDA 510(k) clearance for the Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on May 7, 2018, 117 days after receiving the submission on January 10, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K180079 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2018
Decision Date May 07, 2018
Days to Decision 117 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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