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FDA 510(k)

S.K. DIAG. ULTRASND. SMALL PARTS SCAN

K-Number: K800531 · 1980-04-10

ApplicantSmithkline Diagnostics, Inc.
Decision Date1980-04-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

S.K. DIAG. ULTRASND. SMALL PARTS SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Smithkline Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800531. 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 S.K. DIAG. ULTRASND. SMALL PARTS SCAN?

S.K. DIAG. ULTRASND. SMALL PARTS SCAN is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K800531.

When did S.K. DIAG. ULTRASND. SMALL PARTS SCAN receive FDA 510(k) clearance?

S.K. DIAG. ULTRASND. SMALL PARTS SCAN received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800531.

Who is the listed applicant for S.K. DIAG. ULTRASND. SMALL PARTS SCAN?

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

What is the FDA product code for S.K. DIAG. ULTRASND. SMALL PARTS SCAN?

The FDA product code for S.K. DIAG. ULTRASND. SMALL PARTS SCAN is IYO.

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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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