CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION

Electrocardiograph

WELCH ALLYN

The following data is part of a premarket notification filed by Welch Allyn with the FDA for Cp150 Electrocardiograph With Spirometry Option.

Pre-market Notification Details

Device IDK141582
510k NumberK141582
Device Name:CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION
ClassificationElectrocardiograph
Applicant WELCH ALLYN 4341 STATE STREET ROAD Skaneateles Falls,  NY  13153
ContactKevin Crossen
CorrespondentKevin Crossen
WELCH ALLYN 4341 STATE STREET ROAD Skaneateles Falls,  NY  13153
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-13
Decision Date2014-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094192254 K141582 000
00732094069891 K141582 000
00732094070132 K141582 000
00732094070194 K141582 000
00732094070415 K141582 000
00732094088595 K141582 000
00732094088601 K141582 000
00732094088625 K141582 000
00732094088816 K141582 000
00732094088847 K141582 000
00732094089110 K141582 000
00732094089134 K141582 000
00732094089325 K141582 000
00732094142488 K141582 000
00732094177633 K141582 000
00732094177640 K141582 000
00732094179637 K141582 000
00732094322415 K141582 000

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