ORL Video NasoPharyngo-Larngoscope

Laryngoscope, Nasopharyngoscope

JEDMED INSTRUMENT COMPANY

The following data is part of a premarket notification filed by Jedmed Instrument Company with the FDA for Orl Video Nasopharyngo-larngoscope.

Pre-market Notification Details

Device IDK150248
510k NumberK150248
Device Name:ORL Video NasoPharyngo-Larngoscope
ClassificationLaryngoscope, Nasopharyngoscope
Applicant JEDMED INSTRUMENT COMPANY 5416 JEDMED COURT St. Louis,  MO  63129
ContactCraig Parks
CorrespondentCraig Parks
JEDMED INSTRUMENT COMPANY 5416 JEDMED COURT St. Louis,  MO  63129
Product CodeEQN  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-03
Decision Date2015-07-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B809M2052203101010 K150248 000
B809M205240310101 K150248 000
B809M205220310101 K150248 000
B809M105220300700 K150248 000

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