Mass Casualty Ventilators, Models: MCV200 and MCV200-B
FDA 510(k) K083385 · Allied Healthcare Products, Inc.
510(k) numberK083385
Submission
- Device name
- Mass Casualty Ventilators, Models: MCV200 and MCV200-B
- Applicant
- Allied Healthcare Products, Inc.
Saint Louis, MO, US - Received
- November 17, 2008
- Decision date
- May 14, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K242769 | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)BTL · Traditional | Draegerwerk AG & CO Kgaa | 04/04/2025SE |
| K221634 | Oxymag - Transport and Emergency VentilatorBTL · Traditional | Magnamed Tecnologia Medica S/A | 05/24/2023SE |
| K202219 | VORTRAN GO2VENT with PEEP ValveBTL · Traditional | Vortran Medical Technology 1, Inc. | 02/11/2021SE |
| K193191 | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bagBTL · Traditional | Weinmann Emergency Medical Technology GmbH + Co.… | 11/20/2020SE |
| K182956 | Puffin Lite Infant Resuscitation SystemBTL · Special | International Biomedical | 01/18/2019SE |
| K173373 | SafeT T-Piece ResuscitatorBTL · Traditional | Ventlab, LLC | 11/16/2018SE |
| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
| K162968 | Vortran GO2VENTBTL · Traditional | Vortran Medical Technology 1, Inc. | 04/10/2017SE |
| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K131098 | Emergency Portable VentilatorBTL · Traditional | 04/09/2014SE |
| K132021 | Ahp 300, Emergency Portable VentilatorBTL · Traditional | 04/02/2014SE |
| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | 05/18/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | 08/15/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
| K062080 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 10/18/2006SE |
Questions and answers
When was Mass Casualty Ventilators, Models: MCV200 and MCV200-B cleared by the FDA?
Mass Casualty Ventilators, Models: MCV200 and MCV200-B (K083385) received a 510(k) decision of Substantially Equivalent on May 14, 2009, 178 days after the submission was received.
What is the product code of K083385?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.