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FDA 510(k)

IR-192 IMPLANT -- MODIFICATION

K-Number: K923130 · 1992-09-21

ApplicantOmnitron Intl., Inc.
Decision Date1992-09-21
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IR-192 IMPLANT -- MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Omnitron Intl., Inc.. It received FDA 510(k) clearance on 1992-09-21 under 510(k) number K923130. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IR-192 IMPLANT -- MODIFICATION?

IR-192 IMPLANT -- MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-09-21. The listed applicant is Omnitron Intl., Inc.. The 510(k) number is K923130.

When did IR-192 IMPLANT -- MODIFICATION receive FDA 510(k) clearance?

IR-192 IMPLANT -- MODIFICATION received FDA 510(k) clearance on 1992-09-21, under 510(k) number K923130.

Who is the listed applicant for IR-192 IMPLANT -- MODIFICATION?

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

What is the FDA product code for IR-192 IMPLANT -- MODIFICATION?

The FDA product code for IR-192 IMPLANT -- MODIFICATION is KXK.

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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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