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FDA 510(k)

THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER

K-Number: K984639 · 1999-07-12

ApplicantMedison America, Inc.
Decision Date1999-07-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1999-07-12 under 510(k) number K984639. 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 THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER?

THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 1999-07-12. The listed applicant is Medison America, Inc.. The 510(k) number is K984639.

When did THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 1999-07-12, under 510(k) number K984639.

Who is the listed applicant for THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER?

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

What is the FDA product code for THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER?

The FDA product code for THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER is ITX.

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Related Devices (Code: ITX)

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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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