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FDA 510(k)

SIEMENS SI-400

K-Number: K914013 · 1991-12-02

ApplicantSiemens Ultrasound, Inc.
Decision Date1991-12-02
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIEMENS SI-400 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Ultrasound, Inc.. It received FDA 510(k) clearance on 1991-12-02 under 510(k) number K914013. 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 SI-400?

SIEMENS SI-400 is a medical device that received FDA 510(k) clearance on 1991-12-02. The listed applicant is Siemens Ultrasound, Inc.. The 510(k) number is K914013.

When did SIEMENS SI-400 receive FDA 510(k) clearance?

SIEMENS SI-400 received FDA 510(k) clearance on 1991-12-02, under 510(k) number K914013.

Who is the listed applicant for SIEMENS SI-400?

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

What is the FDA product code for SIEMENS SI-400?

The FDA product code for SIEMENS SI-400 is IYO.

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Other records listing Siemens Ultrasound, Inc. as applicant

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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