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510(k) K070541

IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II by Ivivi Technologies, Inc. — Product Code ILX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2008
Date Received
February 26, 2007
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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