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FDA 510(k)

INTERSOURCE 125, MODEL 1251L

K-Number: K984235 · 1999-06-09

ApplicantInternational Brachytherapy, Inc.
Decision Date1999-06-09
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INTERSOURCE 125, MODEL 1251L is the device name listed in this FDA 510(k) record. The listed applicant is International Brachytherapy, Inc.. It received FDA 510(k) clearance on 1999-06-09 under 510(k) number K984235. 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 INTERSOURCE 125, MODEL 1251L?

INTERSOURCE 125, MODEL 1251L is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is International Brachytherapy, Inc.. The 510(k) number is K984235.

When did INTERSOURCE 125, MODEL 1251L receive FDA 510(k) clearance?

INTERSOURCE 125, MODEL 1251L received FDA 510(k) clearance on 1999-06-09, under 510(k) number K984235.

Who is the listed applicant for INTERSOURCE 125, MODEL 1251L?

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

What is the FDA product code for INTERSOURCE 125, MODEL 1251L?

The FDA product code for INTERSOURCE 125, MODEL 1251L is KXK.

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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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