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FDA 510(k)

KC 100 M

K-Number: K834285 · 1984-02-17

ApplicantElscint, Inc.
Decision Date1984-02-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KC 100 M is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1984-02-17 under 510(k) number K834285. 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 KC 100 M?

KC 100 M is a medical device that received FDA 510(k) clearance on 1984-02-17. The listed applicant is Elscint, Inc.. The 510(k) number is K834285.

When did KC 100 M receive FDA 510(k) clearance?

KC 100 M received FDA 510(k) clearance on 1984-02-17, under 510(k) number K834285.

Who is the listed applicant for KC 100 M?

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

What is the FDA product code for KC 100 M?

The FDA product code for KC 100 M is IYO.

Other records listing Elscint, Inc. as applicant

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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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