PHILIPS ECG LEADWIRE SET

Cable, Transducer And Electrode, Patient, (including Connector)

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Ecg Leadwire Set.

Pre-market Notification Details

Device IDK110287
510k NumberK110287
Device Name:PHILIPS ECG LEADWIRE SET
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactPeter Schipelliti
CorrespondentDawn Tibodeau
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-01-31
Decision Date2011-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838034211 K110287 000
20884838072439 K110287 000
20884838072446 K110287 000
20884838075683 K110287 000
20884838075690 K110287 000
20884838075706 K110287 000
20884838075713 K110287 000
20884838075720 K110287 000
20884838075737 K110287 000
20884838075744 K110287 000
20884838075751 K110287 000
00884838025516 K110287 000
00884838025523 K110287 000
00884838025530 K110287 000
00884838025547 K110287 000
00884838034204 K110287 000
00884838026766 K110287 000

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