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FDA 510(k)

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85

K-Number: K180543 · 2018-05-24

ApplicantSamsung Electronics Co., Ltd.
Decision Date2018-05-24
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K180543. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K180543.

When did GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 receive FDA 510(k) clearance?

GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 received FDA 510(k) clearance on 2018-05-24, under 510(k) number K180543.

Who is the listed applicant for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

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

What is the FDA product code for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85?

The FDA product code for GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 is KPR.

Other records listing Samsung Electronics 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.

K261187Hearing Aid FeatureK261011Sleep Apnea Feature (v2.0)K242651GM85K242478GF85 (models GF85-3P, GF85-SP)K240909Samsung ECG App v 1.3 (ECG)K230292Samsung ECG Monitor Application with Irregular Heart Rhythm Notification

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Related Devices (Code: KPR)

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.

K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream HealthK252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.K251167uDR Aurora CXShanghai United Imaging Healthcare Co., Ltd.K250788Definium Tempo SelectGe Hualun Medical Systems 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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