# K964624: Siemens SC9000/SC9015 Bedside Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 11, 1997 after 303 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K946306 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.
- K954632: Siemens SC 9000 ETCO2 Module, Siemens Medical Solutions USA, Inc. (1996) Summary page 2.

## Indications for use
This device is capable of monitaring: ¢ heartrate * respiration rawe * invasive pressure + non-invasive pressure e amrhythmia ¢ emperature * cardiac output s arterial oxygen saturation * pulserate e cardiac output end-tidal carbon dioxide and (central) apnea This device can be connected to third party devices, Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac output monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.¢. Pbysicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessinent of the patent’s medical condition. The device is intended to be used on Adult, Pediatric and Neonatal populations, with rhe exceprion of the parameter Cardiac Output which is intended for use in the adult and pediatric popularions only; and Arrhythmia which is intended for use in the adult population only. MRI Compatibility Statement: ‘The Siemens SCS000/SC9015 Series is not compatible for use in an MRI magnetic field.

Source page: https://510kreport.com/device/K964624
Methodology: https://510kreport.com/methodology