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510(k) K213479

D²RS and D²RS 9090 by Stephanix — Product Code OWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
October 29, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interventional Fluoroscopic X-Ray System
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Interventional fluoroscopy

Other clearances by Stephanix

  • K221335 — D²RS and D²RS 9090 (June 7, 2022)
  • K212515 — MOVIX DReamy (November 3, 2021)

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