DeviceClearance

Hinscope— 510(k) K241397

Substantially Equivalent

Hinlab Sas

FDA 510(k) clearance K241397 for Hinscope, Substantially Equivalent on 2024-11-14. Applicant: Hinlab Sas. Device class: 2.

Clearance details

Applicant
Hinlab Sas
Product code
Code MSX
Device class
Class 2
Regulation
21 CFR 870.2300
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Neuilly Sur Seine, FR
Download summary PDFView on FDA.gov ↗

Recent devices under product code MSX

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Adverse events under product code MSX

product code MSX
Death
59
Total
59

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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