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FDA 510(k)

R-Sensor, R-Sensor

K-Number: K200284 · 2020-02-28

ApplicantRemedi Co., Ltd.
Decision Date2020-02-28
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

R-Sensor, R-Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Remedi Co., Ltd.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K200284. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-Sensor, R-Sensor?

R-Sensor, R-Sensor is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Remedi Co., Ltd.. The 510(k) number is K200284.

When did R-Sensor, R-Sensor receive FDA 510(k) clearance?

R-Sensor, R-Sensor received FDA 510(k) clearance on 2020-02-28, under 510(k) number K200284.

Who is the listed applicant for R-Sensor, R-Sensor?

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

What is the FDA product code for R-Sensor, R-Sensor?

The FDA product code for R-Sensor, R-Sensor is MUH.

Other records listing Remedi Co., Ltd. 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.

K250597REMEX Xcam6K240759REMEX-GR100K212144Remex KA6

Related Devices (Code: MUH)

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.

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Official Source

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

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