AISAP Cardio V1.0— 510(k) K234141

Substantially Equivalent

Aisap

FDA 510(k) clearance K234141 for AISAP Cardio V1.0, Substantially Equivalent on 2024-08-01. Applicant: Aisap. Device class: 2.

Clearance details

Applicant: Aisap
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2023-12-29
Decision date: 2024-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Gan, IL

Download summary PDF View on FDA.gov ↗

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