Cleared Traditional

INTELLIVUE CL RESPIRATION POD

K132320 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Anesthesiology
Mar 2014
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K132320 is an FDA 510(k) clearance for the INTELLIVUE CL RESPIRATION POD, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on March 26, 2014, 244 days after receiving the submission on July 25, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K132320 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2013
Decision Date March 26, 2014
Days to Decision 244 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

Similar Devices — BZQ Monitor, Breathing Frequency

All 173
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K250093 · Linshom Medical, Inc. · Sep 2025
Respiree Cardio- Respiratory Monitor System
K250934 · Respiree Pte, Ltd. · Aug 2025
RTMsense Respiratory Monitoring System
K243183 · Rtm Vital Signs, LLC · Jun 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · Faceheart Corp. · Apr 2025
Philips VSC-MEDlib
K242001 · Philips Medical Systems Nederland B.V. · Apr 2025
Makani Science? Respiration Monitoring System
K233953 · Makani Science, Inc. · Mar 2025