TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)— 510(k) K122214

Substantially Equivalent

Nihon Kohden Corp.

FDA 510(k) clearance K122214 for TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T), Substantially Equivalent on 2013-05-21. Applicant: Nihon Kohden Corp..

Clearance details

Applicant: Nihon Kohden Corp.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2012-07-25
Decision date: 2013-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foothill, CA, 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.