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FDA 510(k)

GU60A & GU60A-65

K-Number: K173828 · 2018-01-12

Decision Date2018-01-12
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GU60A & GU60A-65 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 2018-01-12 under 510(k) number K173828. 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 GU60A & GU60A-65?

GU60A & GU60A-65 is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K173828.

When did GU60A & GU60A-65 receive FDA 510(k) clearance?

GU60A & GU60A-65 received FDA 510(k) clearance on 2018-01-12, under 510(k) number K173828.

Who is the listed applicant for GU60A & GU60A-65?

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 GU60A & GU60A-65?

The FDA product code for GU60A & GU60A-65 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.

View all 25 devices →

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.

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.