PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A

System, Monitoring, Perinatal

PHILIPS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Avalon Cts Cordless Fetal Transducer System, Models M2720a, M2725a, M2726a, M2727a.

Pre-market Notification Details

Device IDK023931
510k NumberK023931
Device Name:PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
ClassificationSystem, Monitoring, Perinatal
Applicant PHILIPS MEDICAL SYSTEMS, INC. NEDERLAND B.V. POSTBUS 10.000 Da Best,  NL 5680
ContactMarkus Stacha
CorrespondentMarkus Stacha
PHILIPS MEDICAL SYSTEMS, INC. NEDERLAND B.V. POSTBUS 10.000 Da Best,  NL 5680
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-11-26
Decision Date2003-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838009431 K023931 000
00884838009424 K023931 000
00884838002692 K023931 000
00884838002685 K023931 000
00884838002678 K023931 000
20884838008629 K023931 000
20884838008346 K023931 000
20884838003235 K023931 000

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