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FDA 510(k)

PROMATRON 3000

K-Number: K901566 · 1990-10-29

ApplicantPromatek Medical Systems, Inc.
Decision Date1990-10-29
Product CodeIKK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PROMATRON 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Promatek Medical Systems, Inc.. It received FDA 510(k) clearance on 1990-10-29 under 510(k) number K901566. The device is classified under product code IKK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROMATRON 3000?

PROMATRON 3000 is a medical device that received FDA 510(k) clearance on 1990-10-29. The listed applicant is Promatek Medical Systems, Inc.. The 510(k) number is K901566.

When did PROMATRON 3000 receive FDA 510(k) clearance?

PROMATRON 3000 received FDA 510(k) clearance on 1990-10-29, under 510(k) number K901566.

Who is the listed applicant for PROMATRON 3000?

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

What is the FDA product code for PROMATRON 3000?

The FDA product code for PROMATRON 3000 is IKK.

Related Clinical Trials

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Related Devices (Code: IKK)

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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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