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FDA 510(k)

HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE

K-Number: K801060 · 1980-06-04

ApplicantSmithkline Diagnostics, Inc.
Decision Date1980-06-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE 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 1980-06-04 under 510(k) number K801060. 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 HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE?

HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Smithkline Diagnostics, Inc.. The 510(k) number is K801060.

When did HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE receive FDA 510(k) clearance?

HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE received FDA 510(k) clearance on 1980-06-04, under 510(k) number K801060.

Who is the listed applicant for HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE?

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 HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE?

The FDA product code for HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE 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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