FDA 510(k)

DeltaWave Nasal Pillow System

K-번호: K253939 · 2026-01-07

결정일2026-01-07

제품 코드BZD

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

결정Substantially Equivalent

기기 요약

DeltaWave Nasal Pillow System is the device name listed in this FDA 510(k) record. The listed applicant is RemSleep Holdings, Inc.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K253939. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DeltaWave Nasal Pillow System?

DeltaWave Nasal Pillow System is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is RemSleep Holdings, Inc.. The 510(k) number is K253939.

When did DeltaWave Nasal Pillow System receive FDA 510(k) clearance?

DeltaWave Nasal Pillow System received FDA 510(k) clearance on 2026-01-07, under 510(k) number K253939.

Who is the listed applicant for DeltaWave Nasal Pillow System?

The FDA 510(k) record lists RemSleep Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeltaWave Nasal Pillow System?

The FDA product code for DeltaWave Nasal Pillow System is BZD.

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DeltaWave Nasal Pillow System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BZD)

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