FDA 510(k)

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION

K-Number: K991805 · 1999-08-02

Decision Date1999-08-02

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1999-08-02 under 510(k) number K991805. 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 ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION?

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION is a medical device that received FDA 510(k) clearance on 1999-08-02. The listed applicant is Acuson Corp.. The 510(k) number is K991805.

When did ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION receive FDA 510(k) clearance?

ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION received FDA 510(k) clearance on 1999-08-02, under 510(k) number K991805.

Who is the listed applicant for ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION?

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 ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION?

The FDA product code for ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.