EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER— 510(k) K063376

Substantially Equivalent

Medica Corp.

FDA 510(k) clearance K063376 for EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER, Substantially Equivalent on 2007-06-25. Applicant: Medica Corp..

Clearance details

Applicant: Medica Corp.
Product code: Code CHL
Advisory panel: Clinical Chemistry
Date received: 2006-11-08
Decision date: 2007-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, 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.