MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS— 510(k) K041127

Clearance details

Applicant

Sterilmed, Inc.

Product code

Code NLF

Device class

Class 2

Regulation

21 CFR 870.2700

Advisory panel

Cardiovascular

Date received

2004-04-30

Decision date

2004-09-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Maple Grove, MN, US

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