K203653

Substantially Equivalent

MRI PPG Patient Cable

Applicant: Ivy Biomedical Systems, Inc.
Product code: LNH
Advisory panel: Radiology
Date received: 2020-12-15
Decision date: 2021-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.