IPROPHY MOBILE

Handpiece, Direct Drive, Ac-powered

NAKANISHI, INC.

The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Iprophy Mobile.

Pre-market Notification Details

Device IDK131578
510k NumberK131578
Device Name:IPROPHY MOBILE
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
ContactDiane Rutherford
CorrespondentDiane Rutherford
NAKANISHI, INC. 1201 RICHARDSON DRIVE SUITE 280 Richardson,  TX  75080
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-31
Decision Date2013-09-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D7022659960 K131578 000
D7022659930 K131578 000
D7022659910 K131578 000
D7022659920 K131578 000
D7020659910 K131578 000
D7020659900 K131578 000

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