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510(k) K864681

CARHILL ONE-WAY RESUSCITATION VALVE by Life Design Systems, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1987
Date Received
December 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
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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