GF85 (models GF85-3P, GF85-SP)
K-Number: K242478 · 2024-09-19
ApplicantSamsung Electronics Co., Ltd.
Decision Date2024-09-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
GF85 (models GF85-3P, GF85-SP) is a medical device manufactured by Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-09-19 under approval number K242478. 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 GF85 (models GF85-3P, GF85-SP)?
GF85 (models GF85-3P, GF85-SP) is a medical device that received FDA 510(k) clearance on 2024-09-19. It is manufactured by Samsung Electronics Co., Ltd.. The 510(k) number is K242478.
When was GF85 (models GF85-3P, GF85-SP) approved by the FDA?
GF85 (models GF85-3P, GF85-SP) received FDA 510(k) clearance on 2024-09-19, under approval number K242478.
What company makes GF85 (models GF85-3P, GF85-SP)?
GF85 (models GF85-3P, GF85-SP) is manufactured by Samsung Electronics Co., Ltd..
What is the FDA product code for GF85 (models GF85-3P, GF85-SP)?
The FDA product code for GF85 (models GF85-3P, GF85-SP) 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.