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510(k) K854458

CUSHION-FLEX TM-CPAP FACE MASK by Life Design Systems, Inc. — Product Code BYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1986
Date Received
November 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Breathing, Positive End Expiratory Pressure
Device Class
Class II
Regulation Number
868.5965
Review Panel
AN
Submission Type

Other clearances by Life Design Systems, Inc.

  • K913714 — MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) (December 1, 1992)
  • K885313 — HUMIDI-FLEX TM (October 11, 1989)
  • K893030 — CHILD SIZE - FILTER FLEX (TM) (September 18, 1989)
  • K892862 — FLEX-CUP PERCUSSOR (May 25, 1989)
  • K892221 — PULMONARY RESUSCITATOR, MODIFICATION (May 18, 1989)
  • K890011 — OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING (March 20, 1989)
  • K890108 — MODIFIED CUSHION-FLEX(TM) (January 24, 1989)
  • K884387 — CUSHION FLEX(TM) (November 17, 1988)
  • K884068 — PULMANEX TM (NEO-NATAL SIZE) (November 16, 1988)
  • K873179 — HEATER WIRE BREATHING CIRCUIT (March 31, 1988)

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