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FDA 510(k)

NEWTOM VGI AND NEWTOM 5G

K-Number: K130442 · 2013-07-03

ApplicantQr S.R.L.
Decision Date2013-07-03
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEWTOM VGI AND NEWTOM 5G is the device name listed in this FDA 510(k) record. The listed applicant is Qr S.R.L.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K130442. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWTOM VGI AND NEWTOM 5G?

NEWTOM VGI AND NEWTOM 5G is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Qr S.R.L.. The 510(k) number is K130442.

When did NEWTOM VGI AND NEWTOM 5G receive FDA 510(k) clearance?

NEWTOM VGI AND NEWTOM 5G received FDA 510(k) clearance on 2013-07-03, under 510(k) number K130442.

Who is the listed applicant for NEWTOM VGI AND NEWTOM 5G?

The FDA 510(k) record lists Qr S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEWTOM VGI AND NEWTOM 5G?

The FDA product code for NEWTOM VGI AND NEWTOM 5G is OAS.

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Other records listing Qr S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151612NewTom VGi evoK110260NEWTOM 5G / NEWTOM 5G VERSION FP

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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