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510(k) K810340

ADULT MASKS & PEDIATRIC MASKS by Todd Industries, Inc. — Product Code BYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1981
Date Received
February 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by Todd Industries, Inc.

  • K810344 — OXYGEN TUBING (March 17, 1981)
  • K810341 — LIFELINE IPPB SET-UP (March 17, 1981)
  • K810361 — CONNECTOR ADAPTERS (March 17, 1981)
  • K810342 — NASAL CANNULA (March 17, 1981)
  • K810343 — NEBULIZERS (March 17, 1981)
  • K810362 — CORRUGATED FLEX TUBING (March 17, 1981)
  • K810339 — NOSECLIP #6118 (March 17, 1981)
  • K810373 — VENTURI MASK/DELIVERY SYSTEM #'S (March 17, 1981)
  • K810374 — CORRUGATED FLEX TUBING #6000, (March 13, 1981)
  • K810430 — VENTURI MASK/DELIVERY SYSTEM #6078 (March 13, 1981)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K945482 — DISPOSABLE, CPAP OXYGEN MASK (September 19, 1995)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)