510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K083325Substantially Equivalent

N-600X with Spd, Oximax N-600X

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083325 is the FDA 510(k) clearance record for N-600X WITH SPD, OXIMAX N-600X, a class II device, cleared for Covidien on under FDA product code DQA (Oximeter). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K083325.

Clearance record

Decision date
Received
(117 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Covidien 6135 Gunbarrel Ave., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQA

Trailing 12 months
11 clearances under product code DQA in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260