OKLand Patient Return Electrode Pad

Electrosurgical, Cutting & Coagulation & Accessories

Auckland Medical Polymer(Tianjin) Co., Ltd.

The following data is part of a premarket notification filed by Auckland Medical Polymer(tianjin) Co., Ltd. with the FDA for Okland Patient Return Electrode Pad.

Pre-market Notification Details

Device IDK183148
510k NumberK183148
Device Name:OKLand Patient Return Electrode Pad
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Auckland Medical Polymer(Tianjin) Co., Ltd. Building D5-2, XEDA International Industrial Park Tianjin,  CN 300385
ContactBei Lei Gao
CorrespondentBei Lei Gao
Auckland Medical Polymer(Tianjin) Co., Ltd. Building D5-2, XEDA International Industrial Park Tianjin,  CN 300385
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-13
Decision Date2020-02-04

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