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510(k) K180079

Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation by Hill-Rom, Inc. — Product Code BZQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 7, 2018
Date Received: January 10, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Monitor, Breathing Frequency
Device Class: Class II
Regulation Number: 868.2375
Review Panel: AN
Submission Type

Other clearances by Hill-Rom, Inc.

K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom H (March 4, 2021)
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K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM (November 16, 2001)
K973705 — CONTOR TABLE SURFACE (August 7, 1998)
K981081 — BRIGHTSTAR (April 29, 1998)
K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
K971366 — INCUWARMER (January 5, 1998)
K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)

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K242001 — Philips VSC-MEDlib (April 4, 2025)
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K242798 — Airmod (February 28, 2025)
K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 11, 2024)
K223681 — Respiree Cardio-Respiratory Monitor (March 8, 2023)
K221555 — Dozee VS (December 15, 2022)