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510(k) K883315

EDENTRACE MULTI-CHARTER MODEL 3700 by Edentec Corp. — Product Code DSF

K883315 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTRACE MULTI-CHARTER MODEL 3700". The FDA issued a decision of Substantially Equivalent on December 28, 1988. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Edentec Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1988
Date Received
August 5, 1988
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 Edentec Corp.

  • K953363 — OXIFLOW DIGITAL RECORDER (February 6, 1996)
  • K953540 — EEE (August 25, 1995)
  • K921819 — EDENTEC MODEL 3710 I DIGITAL PRINTER (October 22, 1993)
  • K913749 — EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 (July 2, 1992)
  • K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER (August 29, 1991)
  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (August 29, 1991)
  • K905575 — MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON (June 20, 1991)
  • K901060 — EDENTEC MODEL 2000W SYSTEM 700 MONITOR (May 15, 1990)
  • K893561 — EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. (August 25, 1989)
  • K892227 — EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (June 20, 1989)

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