OXICARE FINGERTIP PULSE OXIMETER— 510(k) K133090

Substantially Equivalent

Delbio Incorporation

FDA 510(k) clearance K133090 for OXICARE FINGERTIP PULSE OXIMETER, Substantially Equivalent on 2014-02-28. Applicant: Delbio Incorporation.

Clearance details

Applicant: Delbio Incorporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2013-09-30
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Fremont City, 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.