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510(k) K890711

DUAL GRAPH (TM) RECORDER-MONITOR by Somatics, Inc. — Product Code DSF

K890711 is an FDA 510(k) premarket notification submitted by Somatics, Inc. for the device "DUAL GRAPH (TM) RECORDER-MONITOR". The FDA issued a decision of Substantially Equivalent on June 2, 1989. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Somatics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1989
Date Received
February 13, 1989
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 Somatics, Inc.

  • K992269 — VENTIL-A ORAL PROTECTOR (October 25, 1999)
  • K945120 — THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (October 26, 1995)
  • K890710 — DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS (March 14, 1989)
  • K882809 — THYMAPAD (September 27, 1988)
  • K864181 — SOMATICS MOUTH GUARD (BITE BLOCK) (November 3, 1986)
  • K843923 — THYMATRON (December 3, 1984)

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