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510(k) K781325

MARKII VENTIMASKS by Vickers America Medical Corp. — Product Code BYF

K781325 is an FDA 510(k) premarket notification submitted by Vickers America Medical Corp. for the device "MARKII VENTIMASKS". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Vickers America Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
August 1, 1978
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 Vickers America Medical Corp.

  • K840823 — TREONIC C30 (March 23, 1984)
  • K831838 — LABORATORY DATA MGMT SYSTEM SDMS (January 24, 1984)
  • K830748 — RESUSCITAIRE (June 22, 1983)
  • K830936 — TREONIC IP5 (April 12, 1983)
  • K813239 — OXYGENAIRE NURING INCUBATOR (January 28, 1982)
  • K813238 — NEOCARE BABY-CONTROLLED INCUBATOR (January 22, 1982)
  • K811865 — VMA PEDIATRIC APNEA MATTRESS (July 31, 1981)
  • K810792 — NEOCARE TEMPERATURE MONITOR (April 29, 1981)
  • K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR (March 11, 1981)
  • K810571 — NEOCARE OXYGEN MONITOR (March 11, 1981)

Other clearances for product code BYF

  • K955483 — TRACH MASK MODEL (245, 246) (February 28, 1996)
  • K951652 — VENTIMASK MK IV (April 27, 1995)
  • 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)

FDA data resources