Servator M SALF Solution— 510(k) K211842

Substantially Equivalent

S.A.L.F. Spa

FDA 510(k) clearance K211842 for Servator M SALF Solution, Substantially Equivalent on 2021-12-20. Applicant: S.A.L.F. Spa. Device class: 2.

Clearance details

Applicant: S.A.L.F. Spa
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-15
Decision date: 2021-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cenate Sotto, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDL

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K192408 — Custodiol HTK Solution2020-04-24
K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags2017-10-20

More clearances from S.A.L.F. Spa

K230193 — Servator P Plus SALF Solution2023-09-21
K202652 — Servator P SALF Solution with THAM2021-08-19
K190063 — Servator C SALF Solution2019-08-14
K180481 — Servator B SALF Solution2018-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.