Evie Med Ring— 510(k) K241090

Substantially Equivalent

Movano Inc. Dba Movano Health

FDA 510(k) clearance K241090 for Evie Med Ring, Substantially Equivalent on 2024-11-29. Applicant: Movano Inc. Dba Movano Health.

Clearance details

Applicant
Movano Inc. Dba Movano Health
Product code
Code DQA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasanton, CA, US
Download summary PDFView 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, 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.