SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE— 510(k) K893470

Substantially Equivalent

Siemens Medical Electronics

FDA 510(k) clearance K893470 for SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE, Substantially Equivalent on 1989-08-03. Applicant: Siemens Medical Electronics.

Clearance details

Applicant: Siemens Medical Electronics
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1989-05-04
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, 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.