Manujet III
FDA 510(k) K112783 · VBM Medizintechnik GmbH
510(k) numberK112783
Submission
- Device name
- Manujet III
- Applicant
- VBM Medizintechnik GmbH
Baden-Wurttemberg, DE - Received
- September 26, 2011
- Decision date
- December 22, 2011
- 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
Other 510(k)s with product code BTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
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Questions and answers
When was Manujet III cleared by the FDA?
Manujet III (K112783) received a 510(k) decision of Substantially Equivalent on December 22, 2011, 87 days after the submission was received.
What is the product code of K112783?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.