REPROCESSED MASIMO PULSE OXIMETER SENSORS— 510(k) K081238

Substantially Equivalent

Ascent Healthcare Solutions

FDA 510(k) clearance K081238 for REPROCESSED MASIMO PULSE OXIMETER SENSORS, Substantially Equivalent on 2008-07-29. Applicant: Ascent Healthcare Solutions.

Clearance details

Applicant: Ascent Healthcare Solutions
Product code: Code NLF
Advisory panel: Cardiovascular
Date received: 2008-05-01
Decision date: 2008-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.