APNEICARE CONNECTION CENTER/INTERNET ANALYSIS

Ventilatory Effort Recorder

APNEICARE, LLC

The following data is part of a premarket notification filed by Apneicare, Llc with the FDA for Apneicare Connection Center/internet Analysis.

Pre-market Notification Details

Device IDK082968
510k NumberK082968
Device Name:APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
ClassificationVentilatory Effort Recorder
Applicant APNEICARE, LLC 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134 -2958
ContactPaul Dryden
CorrespondentPaul Dryden
APNEICARE, LLC 24301 WOODSAGE DRIVE Bonita Springs,  FL  34134 -2958
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-06
Decision Date2009-01-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G642CC1A0 K082968 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.