Cleared Traditional

Hinscope

K241397 · Hinlab Sas · Cardiovascular

Nov 2024

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K241397 is an FDA 510(k) clearance for the Hinscope, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Hinlab Sas (Neuilly Sur Seine, FR). The FDA issued a Cleared decision on November 14, 2024, 182 days after receiving the submission on May 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K241397 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2024
Decision Date	November 14, 2024
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF