HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A

Electrosurgical, Cutting & Coagulation & Accessories

BARRX MEDICAL, INCORPORATED

The following data is part of a premarket notification filed by Barrx Medical, Incorporated with the FDA for Haloflex Energy Generator, Models 1190a-115a And 1190a-230a.

Pre-market Notification Details

Device IDK092487
510k NumberK092487
Device Name:HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale,  CA  94085
ContactViorica Filimon
CorrespondentViorica Filimon
BARRX MEDICAL, INCORPORATED 540 OAKMEAD PARKWAY Sunnyvale,  CA  94085
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-13
Decision Date2009-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521177796 K092487 000
10884521660694 K092487 000
10884521823624 K092487 000

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