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FDA 510(k)

CS 9300, CS 9300C

K-Number: K103659 · 2011-08-18

ApplicantTrophy
Decision Date2011-08-18
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS 9300, CS 9300C is the device name listed in this FDA 510(k) record. The listed applicant is Trophy. It received FDA 510(k) clearance on 2011-08-18 under 510(k) number K103659. 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 CS 9300, CS 9300C?

CS 9300, CS 9300C is a medical device that received FDA 510(k) clearance on 2011-08-18. The listed applicant is Trophy. The 510(k) number is K103659.

When did CS 9300, CS 9300C receive FDA 510(k) clearance?

CS 9300, CS 9300C received FDA 510(k) clearance on 2011-08-18, under 510(k) number K103659.

Who is the listed applicant for CS 9300, CS 9300C?

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

What is the FDA product code for CS 9300, CS 9300C?

The FDA product code for CS 9300, CS 9300C is OAS.

Other records listing Trophy 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.

K193390CS Model+K200183CS 9600K181136CS 9600K173622CS ImagingK120975CS 8100 CS 8100 ACCESSK113419CS IMAGING

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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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