K220308

Substantially Equivalent

Patient Monitor: RespArray

Applicant: Edan Instruments, Inc.
Product code: MHX
Advisory panel: Cardiovascular
Date received: 2022-02-02
Decision date: 2022-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.