SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101

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 Compatible Reusable Adult Spo2 Finger Sensors, Models S100a-090103 And 300103, S200a-090101 And 300101.

Pre-market Notification Details

Device IDK061931
510k NumberK061931
Device Name:SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
ClassificationOximeter
Applicant SOLARIS MEDICAL TECHNOLOGY, INC. 2355 EAST FLAMINGO ROAD SUITE 201 G Las Vegas,  NV  89119
ContactThomas Kroenke
CorrespondentThomas Kroenke
SOLARIS MEDICAL TECHNOLOGY, INC. 2355 EAST FLAMINGO ROAD SUITE 201 G Las Vegas,  NV  89119
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-07
Decision Date2007-01-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06900234100054 K061931 000
06900234100047 K061931 000

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