PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)

Bronchoscope (flexible Or Rigid)

PENTAX MEDICAL COMPANY

The following data is part of a premarket notification filed by Pentax Medical Company with the FDA for Pentax Video Bronchoscopes (eb Family).

Pre-market Notification Details

Device IDK131028
510k NumberK131028
Device Name:PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)
ClassificationBronchoscope (flexible Or Rigid)
Applicant PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale,  NJ  07645
ContactKrishna Govindarajan
CorrespondentKrishna Govindarajan
PENTAX MEDICAL COMPANY 3 PARAGON DRIVE Montvale,  NJ  07645
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2014-04-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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04961333232185 K131028 000
04961333232178 K131028 000
04961333232161 K131028 000
04961333232154 K131028 000
04961333254996 K131028 000

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