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510(k) K965203

RADX SYSTEM by Electro Medical Systems, Inc. — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1997
Date Received
December 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Electro Medical Systems, Inc.

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  • K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) (August 24, 2001)
  • K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL (October 4, 2000)
  • K991857 — AIRFLOW HANDY (October 7, 1999)
  • K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE (July 27, 1999)
  • K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER (February 13, 1997)
  • K964111 — LITHOVAC SUCTION/ASPIRATION PROBE (December 16, 1996)
  • K953026 — MINIPIEZON (August 28, 1995)
  • K951531 — SWISS LITHOCLAST LITHOTRIPTER (August 24, 1995)

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