EasyInstruments

Electrosurgical, Cutting & Coagulation & Accessories

Agency For Medical Innovations GmbH

The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for Easyinstruments.

Pre-market Notification Details

Device IDK182013
510k NumberK182013
Device Name:EasyInstruments
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Agency For Medical Innovations GmbH Im Letten 1 Feldkirch,  AT 6800
ContactMartin Hohlrieder
CorrespondentPierre Bounaud
Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego,  CA  92110
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-27
Decision Date2019-03-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EAMIEAH10100 K182013 000
EAMIECM10111 K182013 000
EAMIEDI10200 K182013 000
EAMIEDI10311 K182013 000
EAMIEDI10511 K182013 000
EAMIEDM10100 K182013 000
EAMIEDM10111 K182013 000
EAMIEFG10100 K182013 000
EAMIEFG10111 K182013 000
EAMIEIH10100 K182013 000
EAMIEIR13100 K182013 000
EAMIECM10100 K182013 000
EAMIECI10311 K182013 000
EAMIEAS13100 K182013 000
EAMIEAS13200 K182013 000
EAMIEAS15100 K182013 000
EAMIEAS15200 K182013 000
EAMIEAS15300 K182013 000
EAMIECA10200 K182013 000
EAMIECA10300 K182013 000
EAMIECA10400 K182013 000
EAMIECA11100 K182013 000
EAMIECI10201 K182013 000
EAMIEIR13200 K182013 000
EAMIEIR15100 K182013 000
EAMIEIR15200 K182013 000
EAMIESI11511 K182013 000
EAMIESI12101 K182013 000
EAMIESI13100 K182013 000
EAMIESI13200 K182013 000
EAMIESI15100 K182013 000
EAMIESI15200 K182013 000
EAMIESI15300 K182013 000
EAMIESM10100 K182013 000
EAMIESM10111 K182013 000
EAMIEVI10100 K182013 000
EAMIESI11400 K182013 000
EAMIESI11311 K182013 000
EAMIEIR15300 K182013 000
EAMIERH10100 K182013 000
EAMIESF10111 K182013 000
EAMIESG10111 K182013 000
EAMIESH13100 K182013 000
EAMIESH13200 K182013 000
EAMIESH15100 K182013 000
EAMIESH15200 K182013 000
EAMIESH15300 K182013 000
EAMIESI11200 K182013 000
EAMIEVI10111 K182013 000

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