Cleared Traditional

K955743 - SIEMENS SC 6000/SC 6000 P PORTABLE BEDS...

K955743 is the FDA 510(k) clearance for SIEMENS SC 6000/SC 6000 P PORTABLE BEDS... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K955743 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Jul 1996
Decision
203d
Days
Class 2
Risk

K955743 is an FDA 510(k) clearance for the SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on July 8, 1996 after a review of 203 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K955743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date July 08, 1996
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 225
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