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510(k) K951652

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

K951652 is an FDA 510(k) premarket notification submitted by Flexicare Medical, Ltd. for the device "VENTIMASK MK IV". The FDA issued a decision of Substantially Equivalent on April 27, 1995. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Flexicare Medical, Ltd. has at least 6 other 510(k) clearances on record.

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

Other clearances by Flexicare Medical, Ltd.

  • K150900 — Flexicare Heated Wire Breathing Systems (May 15, 2015)
  • K140473 — DUALGUARD (April 10, 2014)
  • K140113 — O2 NASAL CANNULA WITH CO2 MONITORING (March 6, 2014)
  • K132619 — CLASSIC INTERMITTENT CATHETER (October 11, 2013)
  • K092218 — FLEXICARE BREATHING FILTERS (October 6, 2009)
  • K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES (June 17, 2009)

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)

FDA data resources