SMARTMONITOR 2PS

Monitor, Apnea, Home Use

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Smartmonitor 2ps.

Pre-market Notification Details

Device IDK061256
510k NumberK061256
Device Name:SMARTMONITOR 2PS
ClassificationMonitor, Apnea, Home Use
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactZita A Yurko
CorrespondentZita A Yurko
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeNPF  
CFR Regulation Number868.2377 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-04
Decision Date2006-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B0361038141 K061256 000
B0361038140 K061256 000
B0361030271 K061256 000
B0361028971 K061256 000
B0361028970 K061256 000
B0361014557 K061256 000

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