FDA 510(k)

SML-OSA2 Appliances

K-번호: K162816 · 2017-07-27

결정일2017-07-27

제품 코드LQZ

자문 위원회DE

결정Substantially Equivalent

기기 요약

SML-OSA2 Appliances is the device name listed in this FDA 510(k) record. The listed applicant is Selane Products, Inc.. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K162816. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SML-OSA2 Appliances?

SML-OSA2 Appliances is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Selane Products, Inc.. The 510(k) number is K162816.

When did SML-OSA2 Appliances receive FDA 510(k) clearance?

SML-OSA2 Appliances received FDA 510(k) clearance on 2017-07-27, under 510(k) number K162816.

Who is the listed applicant for SML-OSA2 Appliances?

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

What is the FDA product code for SML-OSA2 Appliances?

The FDA product code for SML-OSA2 Appliances is LQZ.

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SML-OSA2 Appliances

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LQZ)

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