Accu O2 Oxygen Analyzer— 510(k) K173807

Substantially Equivalent

Precision Medical, Inc.

FDA 510(k) clearance K173807 for Accu O2 Oxygen Analyzer, Substantially Equivalent on 2018-05-02. Applicant: Precision Medical, Inc..

Clearance details

Applicant: Precision Medical, Inc.
Product code: Code CCL
Advisory panel: Anesthesiology
Date received: 2017-12-15
Decision date: 2018-05-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Northampton, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCL

product code CCL

Other: 2
Total: 2

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.