PENTAX BRONCHOFIBERSCOPE #FB-19E

Bronchoscope (flexible Or Rigid)

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Pentax Bronchofiberscope #fb-19e.

Pre-market Notification Details

Device IDK822844
510k NumberK822844
Device Name:PENTAX BRONCHOFIBERSCOPE #FB-19E
ClassificationBronchoscope (flexible Or Rigid)
Applicant PENTAX PRECISION INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-23
Decision Date1982-10-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.