N-600X WITH SPD, OXIMAX N-600X

FDA 510(k) Premarket Notification · Submission K083325 · Applicant: Covidien

Public Record 510(k) Submission Decision Date: 2009-03-09 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K083325.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K083325
Applicant / Sponsor
Device Name
N-600X WITH SPD, OXIMAX N-600X
Product Code
DQA
Decision Date
2009-03-09
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Traditional
Third Party Flag
N
Date Received
2008-11-12

Related Establishments / Registrations

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