DATEX-OHMEDA TONOMETRY MODULE M-TONO— 510(k) K993656

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K993656 for DATEX-OHMEDA TONOMETRY MODULE M-TONO, Substantially Equivalent on 2000-03-15. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1999-10-29
Decision date: 2000-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksburt, 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.