510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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EB Neuro S.p.A.

Arbizzano di Valpolicella Verona, IT

EB NEURO S.P.A. appears in FDA device records in Arbizzano di Valpolicella Verona, IT. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 13 510(k) clearances for EB Neuro S.p.A. between 2001 and 2024. The busiest year on record is 2004, with 2. The most recent is 2024, with 2.

Clearances by year, as a table
510(k) clearance decisions for EB Neuro S.p.A., by decision year
YearClearances
20011
20042
20062
20081
20101
20121
20141
20152
20242
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242832NExT Station; NExT Station AdvancedGWLSubstantially Equivalent
K242305BE Plus PRO, Neurotravel LIGHTGWLSubstantially Equivalent
K150220STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-FastGWFSubstantially Equivalent
K142064GALILEO NTOLTSubstantially Equivalent
K133517NEMUS 2 SYSTEMGWLSubstantially Equivalent
K121996BE PLUS LTM AMPLIFIER GWI AMPLIFIERGWLSubstantially Equivalent
K093728BE MICRO, TREAOLVSubstantially Equivalent
K073415NEMUS SYSTEM; NEMUS PC PERIPHERALIKNSubstantially Equivalent
K061996SANDMAN POCKETMNRSubstantially Equivalent
K053606BE PLUS / AURA-LTM64 AMPLIFIERGWLSubstantially Equivalent
K041198NIC36 AMPLIFIERGWLSubstantially Equivalent
K040113SANDMAN SD20 AMPLIFIERGWLSubstantially Equivalent
K003154MIZAR, BASIS BE, SANDMAN DIGITALGWLSubstantially Equivalent

Registered establishments

FDA registered establishments for EB Neuro S.p.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30016877383001687738EB NEURO S.P.A.Via Bologna 1, Arbizzano di Valpolicella Verona 37020 IT2026
96172863003208775EB NEURO, S.P.A.VIA PIETRO FANFANI 97/A, FLORENCE Tuscany 50127 IT2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain