MODIFICATION TO HIOX

Valve, Non-rebreathing

SENSOR MEDICS CORP.

The following data is part of a premarket notification filed by Sensor Medics Corp. with the FDA for Modification To Hiox.

Pre-market Notification Details

Device IDK030943
510k NumberK030943
Device Name:MODIFICATION TO HIOX
ClassificationValve, Non-rebreathing
Applicant SENSOR MEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda,  CA  92887
ContactEarl W Draper
CorrespondentEarl W Draper
SENSOR MEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda,  CA  92887
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-26
Decision Date2003-04-22
Summary:summary

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