Cleared Traditional

K963400 - NELLCOR SYMPHONY N-3000 PATIENT MONITOR...

K963400 is an FDA 510(k) clearance for NELLCOR SYMPHONY N-3000 PATIENT MONITOR..., manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K963400 · Nellcor Puritan Bennett, Inc. · Cardiovascular device
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Nov 1996
Decision
89d
Days
Class 2
Risk

K963400 is an FDA 510(k) clearance for the NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/.... Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 26, 1996 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K963400

510(k) Number K963400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date November 26, 1996
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K963400.
SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
K964784 · Quinton, Inc. · Aug 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
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ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · Alexander Mfg. Co. · May 1997
AS/3 LIGHT MONITOR
K961247 · Datex Division Instrumentarium Corp. · Oct 1996
HP CATHSTATION - MODEL M1264B
K961401 · Hewlett-Packard Co. · Oct 1996
PATIENT MONITOR MODEL 405P
K955546 · Ivy Biomedical Systems, Inc. · Aug 1996