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FDA 510(k)

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER

K-Number: K081148 · 2008-12-22

ApplicantSiemens Medical Solutions USA, Inc., Ultrasound DI
Decision Date2008-12-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. It received FDA 510(k) clearance on 2008-12-22 under 510(k) number K081148. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER?

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER is a medical device that received FDA 510(k) clearance on 2008-12-22. The listed applicant is Siemens Medical Solutions USA, Inc., Ultrasound DI. The 510(k) number is K081148.

When did SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER receive FDA 510(k) clearance?

SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER received FDA 510(k) clearance on 2008-12-22, under 510(k) number K081148.

Who is the listed applicant for SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER?

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

What is the FDA product code for SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER?

The FDA product code for SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER is IYO.

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Other records listing Siemens Medical Solutions USA, Inc., Ultrasound DI as applicant

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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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