FDA 510(k)

ivWatch 모델 400, 장치 액세서리: 확장 모듈, SmartTouch 센서, 환자 케이블

K-번호: K192385 · 2020-07-02

결정일2020-07-02

제품 코드PMS

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Ivwatch, LLC를 신청인으로 등재한 기타 기록

K233881ivWatch® 모델 400 K222212ivWatch 모델 400 K162478ivWatch K153605ivWatch 모델 400

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