Av 800 Ventilator
FDA 510(k) K010317 · Penlon , Ltd.
510(k) numberK010317
Submission
- Device name
- Av 800 Ventilator
- Applicant
- Penlon , Ltd.
Oxfordshire, GB - Received
- February 2, 2001
- Decision date
- July 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
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| K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454CAD · Traditional | 03/03/2006SE |
| K051222 | Av-S Anaesthesia VentilatorCBK · Traditional | 09/23/2005SE |
| K041076 | Delta TCAD · Special | 08/09/2004SE |
| K010318 | Prima Oxygen MonitorCCL · Traditional | 07/23/2001SE |
| K002343 | Sigma DeltaCAD · Traditional | 06/08/2001SE |
| K961468 | Quik-Fil Vaporizer Keyed FillerCAD · Traditional | 07/16/1996SE |
| K960944 | PPV Vaporizer (Modification)CAD · Traditional | 04/02/1996SE |
| K953179 | CLM LaryngoscopeCCW · Traditional | 10/06/1995SE |
Questions and answers
When was Av 800 Ventilator cleared by the FDA?
Av 800 Ventilator (K010317) received a 510(k) decision of Substantially Equivalent on July 23, 2001, 171 days after the submission was received.
What is the product code of K010317?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.