Cleared Traditional

8ch Flex Suite

K200836 · Shenzhen RF Tech Co., Ltd. · Radiology
Jul 2020
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K200836 is an FDA 510(k) clearance for the 8ch Flex Suite, a Coil, Magnetic Resonance, Specialty (Class II — Special Controls, product code MOS), submitted by Shenzhen RF Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 22, 2020, 113 days after receiving the submission on March 31, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K200836 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2020
Decision Date July 22, 2020
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MOS — Coil, Magnetic Resonance, Specialty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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