Infrarax Device
FDA 510(k) K850852 · Medicon, Inc.
510(k) numberK850852
Submission
- Device name
- Infrarax Device
- Applicant
- Medicon, Inc.
Norwalk, CT, US - Received
- March 1, 1985
- Decision date
- August 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Infrarax Device cleared by the FDA?
Infrarax Device (K850852) received a 510(k) decision of Substantially Equivalent on August 21, 1985, 173 days after the submission was received.
What is the product code of K850852?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.