Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors— 510(k) K191018

Name: FDA 510(k) clearance K191018
Creator: U.S. Food and Drug Administration
Published: 2019-07-03

Substantially Equivalent

Surgical Instrument Service and Savings, Inc.

FDA 510(k) clearance K191018 for Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors, Substantially Equivalent on 2019-07-03. Applicant: Surgical Instrument Service and Savings, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Instrument Service and Savings, Inc.
Product code: Code NLF
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2019-04-17
Decision date: 2019-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, OR, US

Download summary PDF View on FDA.gov ↗

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