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FDA 510(k)

SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM

K-Number: K962291 · 1997-01-29

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1997-01-29
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1997-01-29 under 510(k) number K962291. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM?

SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-29. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K962291.

When did SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM receive FDA 510(k) clearance?

SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM received FDA 510(k) clearance on 1997-01-29, under 510(k) number K962291.

Who is the listed applicant for SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM?

The FDA product code for SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM is DSI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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