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510(k) K932797

PRESSURE LIMITING ELBOW by Engineered Medical Systems — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1993
Date Received
June 9, 1993
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

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  • K023683 — MULTI-STRAP FULL FACE MASK (December 1, 2003)
  • K013728 — TRACH VOX (July 30, 2002)
  • K013122 — EMS ELECTROSTATIC FLITER AND HME COMBINATION (April 19, 2002)
  • K013089 — EMS HEPA FILTER AND HME COMBINATIONS (March 14, 2002)
  • K013123 — EMS PULMONARY FUNCTION TESTING FILTER (March 14, 2002)
  • K003497 — DISPOSABLE PRESSURE MONITOR (November 30, 2000)
  • K000215 — SWIVEL ELBOW (May 26, 2000)
  • K000314 — INCENTIVE SPIROMETER (April 12, 2000)

Other clearances for product code BTM

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  • 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)