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FDA 510(k)

STC DIAGNOSTIC 8000

K-Number: K935368 · 1995-05-01

ApplicantSherman Technology Corp.
Decision Date1995-05-01
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTIC 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Sherman Technology Corp.. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K935368. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTIC 8000?

STC DIAGNOSTIC 8000 is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Sherman Technology Corp.. The 510(k) number is K935368.

When did STC DIAGNOSTIC 8000 receive FDA 510(k) clearance?

STC DIAGNOSTIC 8000 received FDA 510(k) clearance on 1995-05-01, under 510(k) number K935368.

Who is the listed applicant for STC DIAGNOSTIC 8000?

The FDA 510(k) record lists Sherman Technology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STC DIAGNOSTIC 8000?

The FDA product code for STC DIAGNOSTIC 8000 is IKN.

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Related Devices (Code: IKN)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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