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FDA 510(k)

NEWTOM 3G QR-DVT 9000

K-Number: K041137 · 2004-05-14

ApplicantAperio Services, LLC
Decision Date2004-05-14
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEWTOM 3G QR-DVT 9000 is the device name listed in this FDA 510(k) record. The listed applicant is Aperio Services, LLC. It received FDA 510(k) clearance on 2004-05-14 under 510(k) number K041137. 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 3G QR-DVT 9000?

NEWTOM 3G QR-DVT 9000 is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Aperio Services, LLC. The 510(k) number is K041137.

When did NEWTOM 3G QR-DVT 9000 receive FDA 510(k) clearance?

NEWTOM 3G QR-DVT 9000 received FDA 510(k) clearance on 2004-05-14, under 510(k) number K041137.

Who is the listed applicant for NEWTOM 3G QR-DVT 9000?

The FDA 510(k) record lists Aperio Services, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEWTOM 3G QR-DVT 9000?

The FDA product code for NEWTOM 3G QR-DVT 9000 is OAS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aperio Services, LLC 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.

K003787NEWTOM QR-DVT 9000

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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