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510(k) K860874

VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC by Dhd Medical Products Div. Diemolding Corp. — Product Code BYF

K860874 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRIC". The FDA issued a decision of Substantially Equivalent on March 19, 1986. The device falls under product code BYF (Mask, Oxygen, Low Concentration, Venturi), a Class I device regulated under 21 CFR 868.5600. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1986
Date Received
February 25, 1986
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 Dhd Medical Products Div. Diemolding Corp.

  • K883988 — NON-REBREATHING TEE PIECE (NRTP) (October 7, 1988)
  • K881935 — MICROCIRRUS MEDICAL NEBULIZER (June 22, 1988)
  • K881178 — CUFFCHECK (April 14, 1988)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)
  • K874047 — ASTHMAKIT (February 29, 1988)
  • K873447 — DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR (October 30, 1987)
  • K860878 — BRITISH BREATHING CIRCUIT SYSTEM (March 20, 1986)
  • K860885 — STRAIGHT CONNECTORS, 15MM, 30MM & 19MM (March 20, 1986)
  • K860882 — DISPOSABLE CATHETER (March 20, 1986)
  • K860877 — FLEXTUBE, CONNECTING TUBING (March 20, 1986)

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)
  • 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