FDA 510(k)

Medline ReNewal 再生處理 Masimo LNCS 系列成人及兒童 SpO2 黏貼式感測器

K 號：K191018 · 2019-07-03

申請人Surgical Instrument Service and Savings, Inc.

決定日期2019-07-03

產品代碼NLF

諮詢委員會履歷

決定相當於

器材摘要

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K191018. The device is classified under product code NLF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors?

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K191018.

When did Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors received FDA 510(k) clearance on 2019-07-03, under 510(k) number K191018.

Who is the listed applicant for Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors?

The FDA product code for Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors is NLF.

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