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510(k) K953540

EEE by Edentec Corp. — Product Code BYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1995
Date Received
July 28, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
Review Panel
AN
Submission Type

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

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)
  • K952750 — HUMID-VENT 1 (July 20, 1995)