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FDA 510(k)

IOWA ORAL PERFORMANCE ISNTRUMENT

K-Number: K920091 · 1992-05-20

ApplicantBreakthrough, Inc.
Decision Date1992-05-20
Product CodeIKE
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IOWA ORAL PERFORMANCE ISNTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Breakthrough, Inc.. It received FDA 510(k) clearance on 1992-05-20 under 510(k) number K920091. The device is classified under product code IKE. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOWA ORAL PERFORMANCE ISNTRUMENT?

IOWA ORAL PERFORMANCE ISNTRUMENT is a medical device that received FDA 510(k) clearance on 1992-05-20. The listed applicant is Breakthrough, Inc.. The 510(k) number is K920091.

When did IOWA ORAL PERFORMANCE ISNTRUMENT receive FDA 510(k) clearance?

IOWA ORAL PERFORMANCE ISNTRUMENT received FDA 510(k) clearance on 1992-05-20, under 510(k) number K920091.

Who is the listed applicant for IOWA ORAL PERFORMANCE ISNTRUMENT?

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

What is the FDA product code for IOWA ORAL PERFORMANCE ISNTRUMENT?

The FDA product code for IOWA ORAL PERFORMANCE ISNTRUMENT is IKE.

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Related Devices (Code: IKE)

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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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