Atlas FDA

Spes Medica Subdermal Needle Electrodes

FDA 510(k) clearance K192603 · decided 2019-11-22

Clearance details

K-number
K192603
Device name
Spes Medica Subdermal Needle Electrodes
Applicant
Spes Medica Srl
Decision
Substantially Equivalent
Date received
2019-09-20
Decision date
2019-11-22
Days to decision
63 days
Clearance type
Traditional
Product code
GXZ
Device class
2
Regulation number
882.1350
Medical specialty
Neurology
Advisory committee
Neurology
Location
Battipaglia (Sa), IT
Third-party review
No
Expedited review
No

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MR CONDITIONAL PRESSON ELECTRODE (K130220)Rhythmlink International, LLC2013-07-22
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PRESSON ELECTRODE (K121347)Rhythmlink International, LLC2012-07-12
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Recalls involving this device

No recalls on record reference this clearance.