Plasma IQ

Electrosurgical, Cutting & Coagulation & Accessories

Neauvia North America, Inc

The following data is part of a premarket notification filed by Neauvia North America, Inc with the FDA for Plasma Iq.

Pre-market Notification Details

Device IDK192813
510k NumberK192813
Device Name:Plasma IQ
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Neauvia North America, Inc 8480 Honeycutt Rd Raleigh,  NC  27615
ContactMisty Williams
CorrespondentMisty Williams
Neauvia North America, Inc 8480 Honeycutt Rd Raleigh,  NC  27615
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-01
Decision Date2020-03-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850017374119 K192813 000
00850017374102 K192813 000
00850017374041 K192813 000
00850017374034 K192813 000
00850017374027 K192813 000
00850017374010 K192813 000
00850017374003 K192813 000

Trademark Results [Plasma IQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLASMA IQ
PLASMA IQ
79297164 not registered Live/Pending
BERGER & KRAFT MEDICAL Sp. z o. o.
2020-09-18

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