RAPIDPoint 500e Blood Gas System— 510(k) K192240

Substantially Equivalent

Siemens Healthcare Diagnostics, Inc.

FDA 510(k) clearance K192240 for RAPIDPoint 500e Blood Gas System, Substantially Equivalent on 2020-03-27. Applicant: Siemens Healthcare Diagnostics, Inc..

Clearance details

Applicant: Siemens Healthcare Diagnostics, Inc.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2019-08-19
Decision date: 2020-03-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Norowood, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.