OVS1 VIDEO SYSTEM

Light Source, Fiberoptic, Routine

OLIVE MEDICAL CORP.

The following data is part of a premarket notification filed by Olive Medical Corp. with the FDA for Ovs1 Video System.

Pre-market Notification Details

Device IDK123359
510k NumberK123359
Device Name:OVS1 VIDEO SYSTEM
ClassificationLight Source, Fiberoptic, Routine
Applicant OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City,  UT  84120
ContactBrian Dean
CorrespondentBrian Dean
OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City,  UT  84120
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-10-31
Decision Date2012-12-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705028702 K123359 000

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