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510(k) K903675

MAGNETIC RESONANCE THERAPY DEVICE by Mrt, Inc. — Product Code ILX

K903675 is an FDA 510(k) premarket notification submitted by Mrt, Inc. for the device "MAGNETIC RESONANCE THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on January 17, 1991. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1991
Date Received
August 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

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FDA data resources