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510(k) K862596

DR-2C (MODIFICATION) by General Devices — Product Code DSF

K862596 is an FDA 510(k) premarket notification submitted by General Devices for the device "DR-2C (MODIFICATION)". The FDA issued a decision of Substantially Equivalent on September 26, 1986. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. General Devices has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1986
Date Received
June 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Paper Chart
Device Class
Class I
Regulation Number
870.2810
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)
  • K935839 — GEMSCOM SERIES 5000, (November 10, 1994)
  • 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)
  • K844650 — DR-2C (January 22, 1985)

Other clearances for product code DSF

  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (August 29, 1991)
  • K912929 — DASH IV (August 13, 1991)
  • K905856 — MODEL 556 MONITOR (January 11, 1991)
  • K902586 — GRI LASERGRAPH(TM) ECG PAPER (June 22, 1990)
  • K902230 — COLORADO COLOR IMAGING RECORDER (June 19, 1990)
  • K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER (May 9, 1990)
  • K895111 — TYPE 9541 RECORDER, PAPER CHART (January 26, 1990)
  • K894922 — WR3500 AND WR3600 SERIES RECORDERS (January 26, 1990)
  • K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
  • K894607 — PAQ10 PAPER CHART RECORDER (October 26, 1989)

FDA data resources