FDA 510(k)

HepaShield Bacterial Viral Breathing System Filter

K-번호: K191909 · 2020-03-23

결정일2020-03-23

제품 코드CAH

자문 위원회AN

결정Substantially Equivalent

기기 요약

HepaShield Bacterial Viral Breathing System Filter is the device name listed in this FDA 510(k) record. The listed applicant is Flexicare Medical Limited.. It received FDA 510(k) clearance on 2020-03-23 under 510(k) number K191909. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the HepaShield Bacterial Viral Breathing System Filter?

HepaShield Bacterial Viral Breathing System Filter is a medical device that received FDA 510(k) clearance on 2020-03-23. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K191909.

When did HepaShield Bacterial Viral Breathing System Filter receive FDA 510(k) clearance?

HepaShield Bacterial Viral Breathing System Filter received FDA 510(k) clearance on 2020-03-23, under 510(k) number K191909.

Who is the listed applicant for HepaShield Bacterial Viral Breathing System Filter?

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

What is the FDA product code for HepaShield Bacterial Viral Breathing System Filter?

The FDA product code for HepaShield Bacterial Viral Breathing System Filter is CAH.

Flexicare Medical Limited.를 신청인으로 등재한 기타 기록

K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)K251448FL-10000U Respiratory Humidifier K250243ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U)K201666SINGLE USE MANOMETER K181583성인 단일 사용 재생산자 백 없음, 성인 단일 사용 재생산자 백 + 압력 해소 40CMH20, 성인 단일 사용 재생산자 백 + 압력 해소 60CMH20, 소아 단일 사용 재생산자 백 + 압력 해소 40CMH20, 유아 단일 사용 재생산자 백 + 압력 해소 40CMH20 K163300ThermoShield HME Filter

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