LIFECARD CF 7 DAY

Electrocardiograph, Ambulatory (without Analysis)

REYNOLDS MEDICAL LTD.

The following data is part of a premarket notification filed by Reynolds Medical Ltd. with the FDA for Lifecard Cf 7 Day.

Pre-market Notification Details

Device IDK011837
510k NumberK011837
Device Name:LIFECARD CF 7 DAY
ClassificationElectrocardiograph, Ambulatory (without Analysis)
Applicant REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights,  NJ  07604
ContactGeorge Myers
CorrespondentGeorge Myers
REYNOLDS MEDICAL LTD. 377 RT. 17 S. Hasbrouck Heights,  NJ  07604
Product CodeMWJ  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-12
Decision Date2001-07-13
Summary:summary

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