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FDA 510(k)

GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM

K-Number: K983436 · 1998-10-29

ApplicantGammamed USA
Decision Date1998-10-29
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gammamed USA. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K983436. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM?

GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Gammamed USA. The 510(k) number is K983436.

When did GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM receive FDA 510(k) clearance?

GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM received FDA 510(k) clearance on 1998-10-29, under 510(k) number K983436.

Who is the listed applicant for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM?

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

What is the FDA product code for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM?

The FDA product code for GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM is JAQ.

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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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