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510(k) K991785

MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR by Instrumentation Industries, Inc. — Product Code BTL

K991785 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR". The FDA issued a decision of Substantially Equivalent on August 17, 1999. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1999
Date Received
May 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Instrumentation Industries, Inc.

  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K162753 — RTC 26-C Inline Aerosol Adapter (February 28, 2017)
  • K113644 — PILOT TUBE REPAIR KIT (January 26, 2012)
  • K102127 — ENDOTRACHEAL TUBE CHANGERS (August 27, 2010)
  • K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (July 22, 2010)
  • K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI AD (December 2, 2009)
  • K081778 — NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (September 12, 2008)
  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • K991355 — METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (January 27, 2000)
  • K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (September 17, 1999)

Other clearances for product code BTL

  • K242769 — VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (April 4, 2025)
  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)

FDA data resources