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FDA 510(k)

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)

K-Number: K930964 · 1994-10-26

ApplicantAcuson Corp.
Decision Date1994-10-26
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1994-10-26 under 510(k) number K930964. 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 ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)?

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) is a medical device that received FDA 510(k) clearance on 1994-10-26. The listed applicant is Acuson Corp.. The 510(k) number is K930964.

When did ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) receive FDA 510(k) clearance?

ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) received FDA 510(k) clearance on 1994-10-26, under 510(k) number K930964.

Who is the listed applicant for ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)?

The FDA 510(k) record lists Acuson Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)?

The FDA product code for ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) is IYO.

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Other records listing Acuson Corp. 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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