HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL

Oximeter

MENNEN MEDICAL, INC.

The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Pulse Oximetry (sao2) Monitor Capabil.

Pre-market Notification Details

Device IDK901774
510k NumberK901774
Device Name:HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
ClassificationOximeter
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactG Whitehead
CorrespondentG Whitehead
MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-19
Decision Date1990-05-22

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