MODIFICATION TO DATACAPTOR

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

CAPSULE TECHNOLOGIE

The following data is part of a premarket notification filed by Capsule Technologie with the FDA for Modification To Datacaptor.

Pre-market Notification Details

Device IDK020197
510k NumberK020197
Device Name:MODIFICATION TO DATACAPTOR
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant CAPSULE TECHNOLOGIE PO BOX 7007 Deerfield,  IL  60015
ContactDaniel Kamm
CorrespondentDaniel Kamm
CAPSULE TECHNOLOGIE PO BOX 7007 Deerfield,  IL  60015
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-22
Decision Date2002-02-21
Summary:summary

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