Bnos Microvent, Model Ac and Model Ao
FDA 510(k) K944397 · Racal Health & Safety, Inc.
510(k) numberK944397
Submission
- Device name
- Bnos Microvent, Model Ac and Model Ao
- Applicant
- Racal Health & Safety, Inc.
Frederick, MD, US - Received
- September 8, 1994
- Decision date
- January 31, 1995
- Decision
- Unknown (SESK)
- 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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| 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 Bnos Microvent, Model Ac and Model Ao cleared by the FDA?
Bnos Microvent, Model Ac and Model Ao (K944397) received a 510(k) decision of Unknown on January 31, 1995, 145 days after the submission was received.
What is the product code of K944397?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.