NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM— 510(k) K110648

Name: FDA 510(k) clearance K110648
Creator: U.S. Food and Drug Administration
Published: 2011-08-29

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K110648 for NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM, Substantially Equivalent on 2011-08-29. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CHL
Device class: Class 2
Regulation: 21 CFR 862.1120
Advisory panel: Clinical Chemistry
Date received: 2011-03-04
Decision date: 2011-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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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.