SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES

Oximeter

SOLARIS MEDICAL TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Solaris Medical Technology, Inc. with the FDA for Solaris Models Nt1 And Nt1a Handheld Pulse Oximeters With Sensor Accessories.

Pre-market Notification Details

Device IDK092950
510k NumberK092950
Device Name:SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
ClassificationOximeter
Applicant SOLARIS MEDICAL TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
ContactSusan D Goldstein-falk
CorrespondentSusan D Goldstein-falk
SOLARIS MEDICAL TECHNOLOGY, INC. 55 Northern Blvd. Suite 200 Great Neck,  NY  11021
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-24
Decision Date2010-03-12
Summary:summary

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