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510(k) K834250

RESCUE MASK by Rondex Products, Inc. — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1984
Date Received
December 7, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
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)
  • K881931 — RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (July 21, 1988)
  • K881393 — RONDEX RESCUE MASK (April 25, 1988)

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  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
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