DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES

Thermometer, Electronic, Clinical

STARBOARD MEDICAL, LLC

The following data is part of a premarket notification filed by Starboard Medical, Llc with the FDA for Disposable Temperature Probes / Sensors And Interconnect Instrument Cables.

Pre-market Notification Details

Device IDK111282
510k NumberK111282
Device Name:DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
ClassificationThermometer, Electronic, Clinical
Applicant STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda,  CA  92887
ContactAnthony Beran
CorrespondentAnthony Beran
STARBOARD MEDICAL, LLC 22845 SAVI RANCH PKWY SUITE H Yorba Linda,  CA  92887
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-06
Decision Date2011-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10850933007105 K111282 000
10850933007099 K111282 000
10850933007082 K111282 000
10897392002746 K111282 000
10897392003095 K111282 000
10897392003088 K111282 000
10080196551644 K111282 000

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