PULSE-OX— 510(k) K863857

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K863857 for PULSE-OX, Substantially Equivalent on 1987-10-07. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1986-10-02
Decision date: 1987-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrollton, TX, 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.