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FDA 510(k)

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER

K-Number: K982937 · 1998-11-19

ApplicantVictoreen, Inc.
Decision Date1998-11-19
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Victoreen, Inc.. It received FDA 510(k) clearance on 1998-11-19 under 510(k) number K982937. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER?

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER is a medical device that received FDA 510(k) clearance on 1998-11-19. The listed applicant is Victoreen, Inc.. The 510(k) number is K982937.

When did MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER receive FDA 510(k) clearance?

MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER received FDA 510(k) clearance on 1998-11-19, under 510(k) number K982937.

Who is the listed applicant for MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER?

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

What is the FDA product code for MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER?

The FDA product code for MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER is LHN.

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Other records listing Victoreen, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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