DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES— 510(k) K052167

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K052167 for DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES, Substantially Equivalent on 2005-09-08. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2005-08-09
Decision date: 2005-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.