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510(k) K905288

ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES by Med-Tek Innovations, Inc. — Product Code BYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1991
Date Received
November 26, 1990
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 Med-Tek Innovations, Inc.

  • K944194 — DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME (September 13, 1994)
  • K913474 — RESPIRE DISPOSABLE PULMONARY RESUSCITATOR (February 3, 1993)

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)