HORIZON 2000 PULSE OXIMETRY AND MODULE

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 And Module.

Pre-market Notification Details

Device IDK882273
510k NumberK882273
Device Name:HORIZON 2000 PULSE OXIMETRY AND MODULE
ClassificationOximeter
Applicant MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence,  NY  14031
ContactThomas W Connelly
CorrespondentThomas W Connelly
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 Received1988-05-31
Decision Date1988-08-25

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