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510(k) K850365

RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE by Eaton Medical Group — Product Code DSF

K850365 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE". The FDA issued a decision of Substantially Equivalent on April 9, 1985. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1985
Date Received
January 30, 1985
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 Eaton Medical Group

  • K851623 — MODEL TRC-40 TELEMETRY RECIEVER MODULE (January 22, 1986)
  • K851624 — MODEL TT-185 TELEMETRY TRANSMITTER (January 14, 1986)
  • K851625 — SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (November 19, 1985)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • K851631 — TMX-C1/C2 TRADMILL CONTROLLER ACCESS. (July 15, 1985)
  • K851629 — TMX-70 TREADMILL (July 9, 1985)
  • K851630 — TMX-80 TREADMILL (July 9, 1985)
  • K851628 — RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO (June 27, 1985)
  • K851626 — SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (June 26, 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