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FDA 510(k)

S.K. DIAG. ULTRASOUND BODY SCANNER

K-Number: K800532 · 1980-04-10

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

Device Summary

S.K. DIAG. ULTRASOUND BODY SCANNER 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 K800532. 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. ULTRASOUND BODY SCANNER?

S.K. DIAG. ULTRASOUND BODY SCANNER 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 K800532.

When did S.K. DIAG. ULTRASOUND BODY SCANNER receive FDA 510(k) clearance?

S.K. DIAG. ULTRASOUND BODY SCANNER received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800532.

Who is the listed applicant for S.K. DIAG. ULTRASOUND BODY SCANNER?

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. ULTRASOUND BODY SCANNER?

The FDA product code for S.K. DIAG. ULTRASOUND BODY SCANNER 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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