FDA 510(k)

Philips IntelliVue GuardianSoftware

K-번호: K180534 · 2018-07-16

신청자Philips Medizin Systeme Boeblingen GmbH

결정일2018-07-16

제품 코드DXJ

자문 위원회CV

결정Substantially Equivalent

기기 요약

Philips IntelliVue GuardianSoftware is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2018-07-16 under 510(k) number K180534. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Philips IntelliVue GuardianSoftware?

Philips IntelliVue GuardianSoftware is a medical device that received FDA 510(k) clearance on 2018-07-16. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K180534.

When did Philips IntelliVue GuardianSoftware receive FDA 510(k) clearance?

Philips IntelliVue GuardianSoftware received FDA 510(k) clearance on 2018-07-16, under 510(k) number K180534.

Who is the listed applicant for Philips IntelliVue GuardianSoftware?

The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Philips IntelliVue GuardianSoftware?

The FDA product code for Philips IntelliVue GuardianSoftware is DXJ.

Philips Medizin Systeme Boeblingen GmbH를 신청인으로 등재한 기타 기록

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