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510(k) K881820

EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER by Edentec Corp. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
April 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
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)
  • K910871 — EDENTEC DIGITAL CHARTER MODEL 3710 (August 29, 1991)
  • K910870 — EDENTEC MODEL 3711 DIGITAL RECORDER (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)

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