DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES— 510(k) K020479

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K020479 for DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES, Substantially Equivalent on 2002-03-26. Applicant: Datex-Ohmeda.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2002-02-13
Decision date: 2002-03-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, 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.