MECALL CLISIS SYSTEMS, Discovery RF180
K-Number: K173395 · 2018-05-21
ApplicantGeneral Medical Merate S.P.A
Decision Date2018-05-21
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
MECALL CLISIS SYSTEMS, Discovery RF180 is a medical device manufactured by General Medical Merate S.P.A. It received FDA 510(k) clearance on 2018-05-21 under approval number K173395. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MECALL CLISIS SYSTEMS, Discovery RF180?
MECALL CLISIS SYSTEMS, Discovery RF180 is a medical device that received FDA 510(k) clearance on 2018-05-21. It is manufactured by General Medical Merate S.P.A. The 510(k) number is K173395.
When was MECALL CLISIS SYSTEMS, Discovery RF180 approved by the FDA?
MECALL CLISIS SYSTEMS, Discovery RF180 received FDA 510(k) clearance on 2018-05-21, under approval number K173395.
What company makes MECALL CLISIS SYSTEMS, Discovery RF180?
MECALL CLISIS SYSTEMS, Discovery RF180 is manufactured by General Medical Merate S.P.A.
What is the FDA product code for MECALL CLISIS SYSTEMS, Discovery RF180?
The FDA product code for MECALL CLISIS SYSTEMS, Discovery RF180 is JAA.
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Official Source
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