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510(k) K161862

ThermoPro by Zimmer Medizinsysteme GmbH — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2016
Date Received
July 6, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code IMJ

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  • K153456 — Megapulse III Shortwave Diathermy (June 14, 2016)
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  • K131899 — SW-THERM (March 14, 2014)
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