INSULCLOCK® v2.0 PRO— 510(k) K241803

Substantially Equivalent

Insulcloud S.L.

FDA 510(k) clearance K241803 for INSULCLOCK® v2.0 PRO, Substantially Equivalent on 2024-08-22. Applicant: Insulcloud S.L.. Device class: 2.

Clearance details

Applicant: Insulcloud S.L.
Product code: Code QOG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2024-06-21
Decision date: 2024-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bibao, ES

Download summary PDF View on FDA.gov ↗

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