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

THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.

K Number: K032858 · Decision Oct 10, 2003
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
12
Review Days
28

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Basic Information

Device Name
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
K Number
K032858
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
870.1025
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Philips Medizin Systeme Boblingen GmbH
Date Received
September 12, 2003
Decision Date
October 10, 2003
Product Code
DSI
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

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

Product Code Device Name
DSI Detector And Alarm, Arrhythmia

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K113657 INTELLIVUE PATIENT MONITOR
K102958 PHILIPS AVALON FETAL MONITOR
K102562 INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
K090360 PHILIPS M3001A MULTI MEASUREMENT SERVER
K083228 PHILIPS INTELLIVUE MP5 PATIENT MONITOR
K060541 THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS
K042845 THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT MONITORS
K031481 THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20
Search all 12 clearances from Philips Medizin Systeme Boblingen GmbH →