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510(k) K893561

EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. by Edentec Corp. — Product Code DSF

K893561 is an FDA 510(k) premarket notification submitted by Edentec Corp. for the device "EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM.". The FDA issued a decision of Substantially Equivalent on Aug 25, 1989. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Edentec Corp. has 17 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 25, 1989
Date Received
May 9, 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
510(k) Exempt

Other clearances by Edentec Corp.

  • K953363 — OXIFLOW DIGITAL RECORDER (Feb 6, 1996)
  • K953540 — EEE (Aug 25, 1995)
  • K921819 — EDENTEC MODEL 3710 I DIGITAL PRINTER (Oct 22, 1993)
  • K913749 — EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170 (Jul 2, 1992)
  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (Aug 29, 1991)
  • K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER (Aug 29, 1991)
  • K905575 — MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON (Jun 20, 1991)
  • K901060 — EDENTEC MODEL 2000W SYSTEM 700 MONITOR (May 15, 1990)
  • K892227 — EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) (Jun 20, 1989)
  • K891540 — EDENTEC MODEL 2860 PRESSURE METER (Jun 1, 1989)

Other clearances for product code DSF

  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (Aug 29, 1991)
  • K912929 — DASH IV (Aug 13, 1991)
  • K905856 — MODEL 556 MONITOR (Jan 11, 1991)
  • K902586 — GRI LASERGRAPH(TM) ECG PAPER (Jun 22, 1990)
  • K902230 — COLORADO COLOR IMAGING RECORDER (Jun 19, 1990)
  • K901385 — GABRIEL MEDICAL CLS THERMAL RECORDER (May 9, 1990)
  • K895111 — TYPE 9541 RECORDER, PAPER CHART (Jan 26, 1990)
  • K894922 — WR3500 AND WR3600 SERIES RECORDERS (Jan 26, 1990)
  • K894736 — MT96000 PAPER CHART RECORDER (Dec 13, 1989)
  • K894607 — PAQ10 PAPER CHART RECORDER (Oct 26, 1989)

FDA data resources