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510(k) K944194

DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME by Med-Tek Innovations, Inc. — Product Code BYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1994
Date Received
August 29, 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-Tek Innovations, Inc.

  • K913474 — RESPIRE DISPOSABLE PULMONARY RESUSCITATOR (February 3, 1993)
  • K905288 — ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES (April 9, 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)
  • K953540 — EEE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)