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510(k) K935839

GEMSCOM SERIES 5000, by General Devices — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1994
Date Received
December 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by General Devices

  • K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (January 18, 2002)
  • K002089 — ROSETTA-LT/ROSETTA-RX (November 21, 2000)
  • K993202 — EIM-107 PREP-CHECK (December 17, 1999)
  • K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (April 14, 1995)
  • K921929 — GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (September 18, 1992)
  • K914889 — GEMSCOM SERIES 3000 (March 4, 1992)
  • K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY (October 9, 1991)
  • K896153 — MODIFIED DR-2C/PMC 100 (January 19, 1990)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)
  • K844650 — DR-2C (January 22, 1985)

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