Avidhrt Sense SpO2— 510(k) K241086

Substantially Equivalent

Avidhrt, Inc.

FDA 510(k) clearance K241086 for Avidhrt Sense SpO2, Substantially Equivalent on 2025-05-09. Applicant: Avidhrt, Inc..

Clearance details

Applicant: Avidhrt, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2024-04-19
Decision date: 2025-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Lansing, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.