GU60A, GU60A-65
K-Number: K182622 · 2018-10-23
ApplicantSamsung Electronics Co., Ltd.
Decision Date2018-10-23
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
GU60A, GU60A-65 is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-10-23 under approval number K182622. 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 2018-10-23. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K182622.
When was GU60A, GU60A-65 approved by the FDA?
GU60A, GU60A-65 received FDA 510(k) clearance on 2018-10-23, under approval number K182622.
What company makes GU60A, GU60A-65?
GU60A, GU60A-65 is manufactured by Samsung Electronics Co., Ltd..
What is the FDA product code for GU60A, GU60A-65?
The FDA product code for GU60A, GU60A-65 is KPR.
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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.