Spes Medica Subdermal Needle Electrodes
K-Number: K192603 · 2019-11-22
ApplicantSpes Medica Srl
Decision Date2019-11-22
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Spes Medica Subdermal Needle Electrodes is a medical device manufactured by Spes Medica Srl. It received FDA 510(k) clearance on 2019-11-22 under approval number K192603. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Spes Medica Subdermal Needle Electrodes?
Spes Medica Subdermal Needle Electrodes is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Spes Medica Srl. The 510(k) number is K192603.
When was Spes Medica Subdermal Needle Electrodes approved by the FDA?
Spes Medica Subdermal Needle Electrodes received FDA 510(k) clearance on 2019-11-22, under approval number K192603.
What company makes Spes Medica Subdermal Needle Electrodes?
Spes Medica Subdermal Needle Electrodes is manufactured by Spes Medica Srl.
What is the FDA product code for Spes Medica Subdermal Needle Electrodes?
The FDA product code for Spes Medica Subdermal Needle Electrodes is GXZ.
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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.