RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE— 510(k) K111773

Clearance details

Applicant

Renu Medical, Inc.

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2011-06-23

Decision date

2011-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Everett, WA, US

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