SMARTRECORDER, MODEL 2500

Ventilatory Effort Recorder

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Smartrecorder, Model 2500.

Pre-market Notification Details

Device IDK990199
510k NumberK990199
Device Name:SMARTRECORDER, MODEL 2500
ClassificationVentilatory Effort Recorder
Applicant RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh,  PA  15221 -4401
ContactBetsy Cortelloni
CorrespondentBetsy Cortelloni
RESPIRONICS, INC. 1501 ARDMORE BLVD. Pittsburgh,  PA  15221 -4401
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-21
Decision Date1999-04-19
Summary:summary

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