PORTA 100HF

System, X-ray, Mobile

JOB CORPORATION

The following data is part of a premarket notification filed by Job Corporation with the FDA for Porta 100hf.

Pre-market Notification Details

Device IDK122697
510k NumberK122697
Device Name:PORTA 100HF
ClassificationSystem, X-ray, Mobile
Applicant JOB CORPORATION 1411 W. 190TH STREET SUITE 120 Gardena,  CA  92048
ContactTakahiro Haruyama
CorrespondentTakahiro Haruyama
JOB CORPORATION 1411 W. 190TH STREET SUITE 120 Gardena,  CA  92048
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-04
Decision Date2012-10-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00458237384007 K122697 000
04582373840071 K122697 000

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