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510(k) K881931

RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR by Rondex Products, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1988
Date Received
May 9, 1988
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 Rondex Products, Inc.

  • K981169 — RONDEX CPR ISO-SHIELD (May 19, 1998)
  • K942671 — CPR SHIELD (February 7, 1995)
  • K943761 — NON-BREATHING VALVE (November 10, 1994)
  • K921002 — RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED (October 6, 1992)
  • K914195 — RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED (November 8, 1991)
  • K914196 — RONDEX MASKS MODELS 9015/9011/901102 MODIFIED (November 8, 1991)
  • K902299 — CPR VALVE (NON-REBREATHING) MODEL #9030 (October 26, 1990)
  • K902298 — ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (August 22, 1990)
  • K881393 — RONDEX RESCUE MASK (April 25, 1988)
  • K834250 — RESCUE MASK (January 18, 1984)

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