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510(k) K946209

DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME by Med-Plastics Intl., Inc. — Product Code BYD

K946209 is an FDA 510(k) premarket notification submitted by Med-Plastics Intl., Inc. for the device "DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME". The FDA issued a decision of Substantially Equivalent on June 8, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Med-Plastics Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1995
Date Received
December 21, 1994
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 Med-Plastics Intl., Inc.

  • K942568 — ADULT ANESTHESIA BREATHING CIRCUIT (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942567 — MASS SPECTROMETRY MONITORING LINES AND CONNECTORS (June 10, 1994)
  • K942570 — MAPLESON D CIRCUIT (June 10, 1994)
  • K942571 — HYPER-INFLATION BAG (June 10, 1994)
  • K932577 — PEDIATRIC GAS SAMPLING (July 22, 1993)
  • K932575 — ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (July 22, 1993)
  • K932576 — PEDIATRIC TEMPERATURE MONITORING CIRCUITS (July 22, 1993)
  • K932578 — ADULT GAS SAMPLING CIRCUITS (July 22, 1993)

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