FDA 510(k)

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable

Número K: K192385 · 2020-07-02

Data da decisão2020-07-02

Código do produtoPMS

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ivwatch, LLC. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K192385. The device is classified under product code PMS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Ivwatch, LLC. The 510(k) number is K192385.

When did ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable receive FDA 510(k) clearance?

ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable received FDA 510(k) clearance on 2020-07-02, under 510(k) number K192385.

Who is the listed applicant for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

The FDA 510(k) record lists Ivwatch, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable?

The FDA product code for ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable is PMS.

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Outros registros que listam Ivwatch, LLC como candidato(a)

K233881ivWatch® Model 400 K222212ivWatch Model 400 K162478ivWatch K153605ivWatch Model 400

Dispositivos Relacionados (Código: PMS)

K233881ivWatch® Model 400Ivwatch, LLC K222212ivWatch Model 400Ivwatch, LLC K162478ivWatchIvwatch, LLC K153605ivWatch Model 400Ivwatch, LLC

Fonte oficial

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