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510(k) K982215

MANUAL RESUSCITATOR WITH ACE by Medical Marketing Concepts — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1998
Date Received
June 23, 1998
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 Medical Marketing Concepts

  • K961867 — PEEP VALVE (August 13, 1996)
  • K961329 — BAGRIGHT CHILD RESUSCITATOR (July 2, 1996)
  • K961330 — BAGRIGHT INFANT RESUSCITATOR (July 2, 1996)
  • K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961882 — RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961868 — RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961369 — BAGRIGHT RESPOSABLE RESUSCITATOR (June 28, 1996)
  • K953546 — MANUAL PULMONARY RESUSICITATOR (February 29, 1996)
  • K954296 — BAGRIGHT RESUSCITATOR (December 20, 1995)

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  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
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