510(k) K153193— Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)

Substantially Equivalent

Zyno Medical, LLC

Clearance details

Applicant: Zyno Medical, LLC
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2015-11-03
Decision date: 2016-08-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Natick, MA, US

Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.