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510(k) K905575

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON by Edentec Corp. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1991
Date Received
December 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Edentec Corp.

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  • 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)
  • 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)
  • K891540 — EDENTEC MODEL 2860 PRESSURE METER (June 1, 1989)

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