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510(k) K951652

VENTIMASK MK IV by Flexicare Medical, Ltd. — Product Code BYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
April 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Low Concentration, Venturi
Device Class
Class I
Regulation Number
868.5600
Review Panel
AN
Submission Type

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Other clearances for product code BYF

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K894457 — CARNATION TRACHEOSTOMY MASKS (October 13, 1989)
  • K860873 — VENTURI MASK/ADULT & PAEDIATRIC (March 20, 1986)
  • K860874 — VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC (March 19, 1986)
  • K852618 — OXY-DIAL (September 18, 1985)
  • K832725 — DUAL DIAL VENTURI STYLE MASK (September 20, 1983)
  • K812066 — PERCENTO MASK, PEDIATRIC, UNDER-THE-CHIN (August 3, 1981)
  • K810947 — AIR ENTRAINMENT TRACH T (June 2, 1981)
  • K810946 — ADULT & PEDIATRIC TRACHEOSTOMY MASKS (June 2, 1981)
  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)