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510(k) K863508

FRANTZ MEDICAL ELECTRODE by Frantz Medical Development, Ltd. — Product Code DXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1987
Date Received
September 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ballistocardiograph
Device Class
Class II
Regulation Number
870.2320
Review Panel
CV
Submission Type

Other clearances by Frantz Medical Development, Ltd.

  • K981541 — CLEARSTAR ENTERAL NUTRITION PUMP (August 13, 1998)
  • K905282 — ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE (March 19, 1991)
  • K873119 — FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (November 5, 1987)
  • K871710 — BIOPSY FORCEPS (August 10, 1987)

Other clearances for product code DXR

  • K243566 — CardioTag™ (July 22, 2025)
  • K160656 — CorSens (November 21, 2016)
  • K081603 — DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (July 24, 2009)
  • K870442 — QUANTASCOPE (August 11, 1987)