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FDA 510(k)

ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K001400 · 2000-08-01

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2000-08-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND 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 2000-08-01 under 510(k) number K001400. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM?

ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-01. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K001400.

When did ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2000-08-01, under 510(k) number K001400.

Who is the listed applicant for ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND 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 ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

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Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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