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510(k) K894922

WR3500 AND WR3600 SERIES RECORDERS by Western Graphtec — Product Code DSF

K894922 is an FDA 510(k) premarket notification submitted by Western Graphtec for the device "WR3500 AND WR3600 SERIES RECORDERS". The FDA issued a decision of Substantially Equivalent on January 26, 1990. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1990
Date Received
August 2, 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 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)
  • K894736 — MT96000 PAPER CHART RECORDER (December 13, 1989)
  • K894607 — PAQ10 PAPER CHART RECORDER (October 26, 1989)
  • K893561 — EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (August 25, 1989)

FDA data resources