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510(k) K923910

HEAT MOISTURE CONDENSER by Concord/Portex — Product Code BYD

K923910 is an FDA 510(k) premarket notification submitted by Concord/Portex for the device "HEAT MOISTURE CONDENSER". The FDA issued a decision of Substantially Equivalent on January 26, 1993. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Concord/Portex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1993
Date Received
August 4, 1992
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

Other clearances by Concord/Portex

  • K923559 — STERI-CATH MDI (October 25, 1993)
  • K930218 — SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (July 27, 1993)
  • K924541 — EPIDURAL MINIPACK (July 9, 1993)
  • K930286 — DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS (June 22, 1993)
  • K923127 — NEEDLE-PRO CARTRIDGE (April 29, 1993)
  • K922749 — LOW PROFILE TRACHEOSTOMY TUBE (September 2, 1992)
  • K922445 — VACU-PRO (August 12, 1992)
  • K915452 — ANESTHESIA BREATHING CIRCUIT (February 14, 1992)
  • K911809 — NEW-VENT (August 26, 1991)
  • K912124 — TRACHEOSTOMY TUBE AND CUFF (August 16, 1991)

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)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 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)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)

FDA data resources