DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT— 510(k) K052755

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K052755 for DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT, Substantially Equivalent on 2005-10-13. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2005-09-30
Decision date: 2005-10-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

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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.