BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO

    K Number: K122223 · Decision Apr 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    48
    Review Days
    261

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
    K Number
    K122223
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medizin Systeme Boeblingen GmbH
    Date Received
    July 25, 2012
    Decision Date
    April 12, 2013
    Product Code
    BZQ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BZQ Monitor, Breathing Frequency

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BZQ), ordered by most recent decision date.

    Respiration Rate algorithm

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Respiree Cardio- Respiratory Monitor System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RTMsense Respiratory Monitoring System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Philips VSC-MEDlib

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Philips Medizin Systeme Boeblingen GmbH

    K Number Device Name
    K252726 IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)
    K251146 IntelliVue Patient monitors MX400, MX450, MX500, MX550
    K233440 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
    K231671 IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468)
    K230604 IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
    K223574 IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)
    K210906 IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
    K212208 Philips IntelliVue GuardianSoftware (Rev. E.0X)
    K192137 IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
    K182979 IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
    Search all 48 clearances from Philips Medizin Systeme Boeblingen GmbH →