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510(k) K833000

I-CHANNEL RECORDER by Litton Medical Electronics — Product Code DSF

K833000 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "I-CHANNEL RECORDER". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Litton Medical Electronics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
August 18, 1983
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 Litton Medical Electronics

  • K840522 — RECOMED BLOOD-FLOW METER H236-052-02 (May 16, 1985)
  • K840439 — RECOMED CARDIAC OUTPUT METER 236067- (November 20, 1984)
  • K840899 — SERVOMED ARRHYCOMP CENTRAL MONITOR SYS (November 20, 1984)
  • K840523 — SERVOMED PULSE AMPLIFIER MODULE-206- (October 29, 1984)
  • K840524 — SERVOMED BASIC BEDSIDE UNIT SMV 110TP (October 26, 1984)
  • K840832 — SERVOMED OXCARDIORE SPIROGRAPH 324/111 (September 20, 1984)
  • K840209 — SERVOMED MEDIVISION SCOPE SMV-235 (September 20, 1984)
  • K832998 — 2-CHANNEL RECORDER (June 1, 1984)
  • K840521 — SERVOMED DIGITAL DISPLAY MODULE (June 1, 1984)
  • K834600 — RECOMB ECG PREAMPLIFIER/206 069 03 (June 1, 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