FDA 510(k)

FL-10000U Respiratory Humidifier

K-번호: K251448 · 2026-01-16

결정일2026-01-16

제품 코드BTT

자문 위원회AN

결정Substantially Equivalent

기기 요약

FL-10000U Respiratory Humidifier 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 2026-01-16 under 510(k) number K251448. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FL-10000U Respiratory Humidifier?

FL-10000U Respiratory Humidifier is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Flexicare Medical Limited.. The 510(k) number is K251448.

When did FL-10000U Respiratory Humidifier receive FDA 510(k) clearance?

FL-10000U Respiratory Humidifier received FDA 510(k) clearance on 2026-01-16, under 510(k) number K251448.

Who is the listed applicant for FL-10000U Respiratory Humidifier?

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 FL-10000U Respiratory Humidifier?

The FDA product code for FL-10000U Respiratory Humidifier is BTT.

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)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 K191909HepaShield Bacterial Viral Breathing System Filter 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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