SAC2 - Electrode Cream
K-Number: K192606 · 2020-01-17
ApplicantSpes Medica Srl
Decision Date2020-01-17
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SAC2 - Electrode Cream is a medical device manufactured by Spes Medica Srl. It received FDA 510(k) clearance on 2020-01-17 under approval number K192606. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SAC2 - Electrode Cream?
SAC2 - Electrode Cream is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Spes Medica Srl. The 510(k) number is K192606.
When was SAC2 - Electrode Cream approved by the FDA?
SAC2 - Electrode Cream received FDA 510(k) clearance on 2020-01-17, under approval number K192606.
What company makes SAC2 - Electrode Cream?
SAC2 - Electrode Cream is manufactured by Spes Medica Srl.
What is the FDA product code for SAC2 - Electrode Cream?
The FDA product code for SAC2 - Electrode Cream is GYB.
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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.