SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER— 510(k) K884329

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K884329 for SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1988-12-16. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1988-10-14
Decision date: 1988-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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.