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510(k) K953546

MANUAL PULMONARY RESUSICITATOR by Medical Marketing Concepts — Product Code BTM

K953546 is an FDA 510(k) premarket notification submitted by Medical Marketing Concepts for the device "MANUAL PULMONARY RESUSICITATOR". The FDA issued a decision of Substantially Equivalent on February 29, 1996. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Medical Marketing Concepts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 1996
Date Received
July 28, 1995
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

  • K982215 — MANUAL RESUSCITATOR WITH ACE (September 18, 1998)
  • K961867 — PEEP VALVE (August 13, 1996)
  • K961330 — BAGRIGHT INFANT RESUSCITATOR (July 2, 1996)
  • K961329 — BAGRIGHT CHILD RESUSCITATOR (July 2, 1996)
  • K961369 — BAGRIGHT RESPOSABLE RESUSCITATOR (June 28, 1996)
  • K961331 — BAGRIGHT RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K961332 — BAGRIGHT RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961882 — RESPOSABLE INFANT RESUSCITATOR (June 28, 1996)
  • K961868 — RESPOSABLE CHILD RESUSCITATOR (June 28, 1996)
  • K954296 — BAGRIGHT RESUSCITATOR (December 20, 1995)

Other clearances for product code BTM

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K243861 — butterflyBVM (April 25, 2025)
  • K221841 — EOlife® (March 18, 2023)
  • K212905 — Sotair Device (August 18, 2022)
  • K210288 — Disposable Manual Resuscitator (August 26, 2021)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K170663 — Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremoun (May 11, 2018)
  • K152931 — Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR (August 29, 2016)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)

FDA data resources