Model 580-006 Radiation Therapy Ionization Chamber

Q: What is the product code of K982937?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.

FDA 510(k) K982937 · Victoreen, Inc.

Substantially Equivalent

510(k) numberK982937

Submission

Device name: Model 580-006 Radiation Therapy Ionization Chamber
Applicant: Victoreen, Inc.
Solon, OH, US
Received: August 21, 1998
Decision date: November 19, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LHN – System, Radiation Therapy, Charged-Particle, Medical
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.5050
Specialty: Radiology

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Questions and answers

When was Model 580-006 Radiation Therapy Ionization Chamber cleared by the FDA?

Model 580-006 Radiation Therapy Ionization Chamber (K982937) received a 510(k) decision of Substantially Equivalent on November 19, 1998, 90 days after the submission was received.

What is the product code of K982937?

The FDA product code is LHN – System, Radiation Therapy, Charged-Particle, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.