REPROCESSED PULSE OXIMETER SENSORS— 510(k) K102560

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K102560 for REPROCESSED PULSE OXIMETER SENSORS, Substantially Equivalent on 2011-02-18. Applicant: Sterilmed, Inc.. Device class: 2.

Clearance details

Applicant
Sterilmed, Inc.
Product code
Code NLF
Device class
Class 2
Regulation
21 CFR 870.2700
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
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