RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO— 510(k) K081927

Clearance details

Applicant

Renu Medical, Inc.

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2008-07-07

Decision date

2009-02-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Everett, WA, US

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