510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963400Substantially Equivalent

Nellcor Symphony N-3000 Patient Monitor with Spo2 and ECG and N-3200 Display/printer

Medtronic, Inc., Lenexa KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963400 is the FDA 510(k) clearance record for NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER, a class II device, cleared for Nellcor Puritan Bennett, Inc. on under FDA product code DPS (Electrocardiograph). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K963400.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DPS Electrocardiograph
Regulation
21 CFR 870.2340
Device class
Class II
Review panel
Cardiovascular
Applicant
Nellcor Puritan Bennett, Inc. 11150 Thompson Ave., Lenexa KS
510(k) summary
Summary
Third party review
No

Clearances, product code DPS

Trailing 12 months
7 clearances under product code DPS in the twelve months to November 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DPS, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20262
October 20262
November 20260