Cleared Traditional

RICH-MAR AUTOPRISM INFRARED LAMP

K040679 · Rich-Mar Corp. · Physical Medicine
May 2004
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K040679 is an FDA 510(k) clearance for the RICH-MAR AUTOPRISM INFRARED LAMP, a Lamp, Infrared, Therapeutic Heating (Class II — Special Controls, product code ILY), submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on May 7, 2004, 53 days after receiving the submission on March 15, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number K040679 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2004
Decision Date May 07, 2004
Days to Decision 53 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILY — Lamp, Infrared, Therapeutic Heating
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5500

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