MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES

Oximeter

MASIMO CORP.

The following data is part of a premarket notification filed by Masimo Corp. with the FDA for Masimo Set/quartz 2500 Pulse Oximeter And Accessories.

Pre-market Notification Details

Device IDK993555
510k NumberK993555
Device Name:MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
ClassificationOximeter
Applicant MASIMO CORP. 2852 KELVIN AVE. Irvine,  CA  92614 -5826
ContactJames J Cronin
CorrespondentJames J Cronin
MASIMO CORP. 2852 KELVIN AVE. Irvine,  CA  92614 -5826
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-20
Decision Date1999-11-19
Summary:summary

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