Cleared Traditional

CloudHRV? System (100-01-001)

K241217 · Inmedix, Inc. · Cardiovascular

Jan 2025

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K241217 is an FDA 510(k) clearance for the CloudHRV? System (100-01-001), a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Inmedix, Inc. (Normandy Park, US). The FDA issued a Cleared decision on January 16, 2025, 260 days after receiving the submission on May 1, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number	K241217 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2024
Decision Date	January 16, 2025
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF