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510(k) K203261

Reprocessed Inquiry Steerable Diagnostic EP Catheter by Innovative Health, LLC — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2021
Date Received
November 5, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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