ART-M1, MODEL M1-1-ART-A1

Scaler, Ultrasonic

BONART CO. LTD.

The following data is part of a premarket notification filed by Bonart Co. Ltd. with the FDA for Art-m1, Model M1-1-art-a1.

Pre-market Notification Details

Device IDK000510
510k NumberK000510
Device Name:ART-M1, MODEL M1-1-ART-A1
ClassificationScaler, Ultrasonic
Applicant BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei,  TW
ContactBankson Tsai
CorrespondentBankson Tsai
BONART CO. LTD. RM. 405, NO.3 WUCHUAN 1ST ROAD Hsinchuang, Taipei,  TW
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-05-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719873120871 K000510 000
04719873121366 K000510 000
04719873121380 K000510 000
04719873120024 K000510 000
04719873120079 K000510 000
04719873120093 K000510 000
04719873120116 K000510 000
04719873120130 K000510 000
04719873120154 K000510 000
04719873120741 K000510 000
04719873120765 K000510 000
04719873120772 K000510 000
04719873121533 K000510 000

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