CloudHRV System (100-01-001)— 510(k) K241217

Substantially Equivalent

Inmedix, Inc.

FDA 510(k) clearance K241217 for CloudHRV System (100-01-001), Substantially Equivalent on 2025-01-16. Applicant: Inmedix, Inc..

Clearance details

Applicant: Inmedix, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2024-05-01
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Normandy Park, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.