E.S.O. (ELECTRO SENSOR OXI)— 510(k) K102442

Substantially Equivalent

Ld Technology, LLC

FDA 510(k) clearance K102442 for E.S.O. (ELECTRO SENSOR OXI), Substantially Equivalent on 2010-09-10. Applicant: Ld Technology, LLC.

Clearance details

Applicant: Ld Technology, LLC
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2010-08-26
Decision date: 2010-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.