FDA 510(k)

Invacare Platinum Mobile Oxygen Concentrator

K-번호: K160630 · 2016-09-27

결정일2016-09-27

제품 코드CAW

자문 위원회AN

결정Substantially Equivalent

기기 요약

Invacare Platinum Mobile Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160630. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Invacare Platinum Mobile Oxygen Concentrator?

Invacare Platinum Mobile Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Invacare Corporation. The 510(k) number is K160630.

When did Invacare Platinum Mobile Oxygen Concentrator receive FDA 510(k) clearance?

Invacare Platinum Mobile Oxygen Concentrator received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160630.

Who is the listed applicant for Invacare Platinum Mobile Oxygen Concentrator?

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

What is the FDA product code for Invacare Platinum Mobile Oxygen Concentrator?

The FDA product code for Invacare Platinum Mobile Oxygen Concentrator is CAW.

Invacare Corporation를 신청인으로 등재한 기타 기록

K203210Invacare Platinum 5NXG Oxygen Concentrator K202379Invacare AVIVA Storm RX Power Chair K200890Invacare Perfecto2V Oxygen Concentrator K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity K182946Invacare TDX SP2-HD with Captain's Seat

14개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.