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FDA 510(k)

SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR

K-Number: K982730 · 1998-08-24

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1998-08-24
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR 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 1998-08-24 under 510(k) number K982730. 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 SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR?

SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K982730.

When did SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR receive FDA 510(k) clearance?

SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR received FDA 510(k) clearance on 1998-08-24, under 510(k) number K982730.

Who is the listed applicant for SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR?

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 SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR?

The FDA product code for SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR 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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