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FDA 510(k)

ZIKON 100 DIGITAL X-RAY SYSTEM

K-Number: K813032 · 1981-11-24

ApplicantKontron Instruments, Inc.
Decision Date1981-11-24
Product CodeJAB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZIKON 100 DIGITAL X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813032. The device is classified under product code JAB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIKON 100 DIGITAL X-RAY SYSTEM?

ZIKON 100 DIGITAL X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K813032.

When did ZIKON 100 DIGITAL X-RAY SYSTEM receive FDA 510(k) clearance?

ZIKON 100 DIGITAL X-RAY SYSTEM received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813032.

Who is the listed applicant for ZIKON 100 DIGITAL X-RAY SYSTEM?

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

What is the FDA product code for ZIKON 100 DIGITAL X-RAY SYSTEM?

The FDA product code for ZIKON 100 DIGITAL X-RAY SYSTEM is JAB.

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Other records listing Kontron Instruments, Inc. as applicant

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Related Devices (Code: JAB)

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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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