AG MASS— 510(k) K131099

Substantially Equivalent

Hospitech Respiration , Ltd.

FDA 510(k) clearance K131099 for AG MASS, Substantially Equivalent on 2013-05-13. Applicant: Hospitech Respiration , Ltd..

Clearance details

Applicant: Hospitech Respiration , Ltd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2013-04-19
Decision date: 2013-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Binyamina, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.