FOX PULSE OXIMETER— 510(k) K051736

Substantially Equivalent

Shunsuke Nakanishi

FDA 510(k) clearance K051736 for FOX PULSE OXIMETER, Substantially Equivalent on 2005-12-02. Applicant: Shunsuke Nakanishi.

Clearance details

Applicant: Shunsuke Nakanishi
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2005-06-28
Decision date: 2005-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marino, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.