Cleared Special

K990563 - SIEMENS SC 8000 BEDSIDE MONITOR WITH AD...

K990563 is the FDA 510(k) clearance for SIEMENS SC 8000 BEDSIDE MONITOR WITH AD... by Siemens Medical Solutions USA, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Special 510(k) pathway after a 25-day FDA review.

K990563 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Mar 1999
Decision
25d
Days
Class 2
Risk

K990563 is an FDA 510(k) clearance for the SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on March 19, 1999 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K990563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date March 19, 1999
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 282
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