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FDA 510(k)

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM

K-Number: K973079 · 1997-11-05

ApplicantAcuson Corp.
Decision Date1997-11-05
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1997-11-05 under 510(k) number K973079. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM?

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-05. The listed applicant is Acuson Corp.. The 510(k) number is K973079.

When did L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM receive FDA 510(k) clearance?

L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM received FDA 510(k) clearance on 1997-11-05, under 510(k) number K973079.

Who is the listed applicant for L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM?

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 L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM?

The FDA product code for L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM is ITX.

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Other records listing Acuson Corp. 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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