GF85 (models GF85-3P, GF85-SP)
K-Number: K242478 · 2024-09-19
Device Summary
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. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K242478.
When did GF85 (models GF85-3P, GF85-SP) receive FDA 510(k) clearance?
GF85 (models GF85-3P, GF85-SP) received FDA 510(k) clearance on 2024-09-19, under 510(k) number K242478.
Who is the listed applicant for GF85 (models GF85-3P, GF85-SP)?
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 GF85 (models GF85-3P, GF85-SP)?
The FDA product code for GF85 (models GF85-3P, GF85-SP) 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.
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.