Ventilator with Respiratory Mechanics, Model 840
FDA 510(k) K063650 · Puritan Bennett Corp.
510(k) numberK063650
Submission
- Device name
- Ventilator with Respiratory Mechanics, Model 840
- Applicant
- Puritan Bennett Corp.
Carlsbad, CA, US - Received
- December 8, 2006
- Decision date
- February 15, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
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More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionCBK · Traditional | 04/04/2006SE |
| K023225 | Puritan Bennett Dataflow Data Management SoftwareBZG · Abbreviated | 12/18/2002SE |
| K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemBZG · Special | 09/27/2002SE |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionCBK · Special | 08/13/2002ST |
| K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionCBK · Traditional | 10/20/2000ST |
| K002001 | Breeze Sleepgear with DreamsealBZD · Special | 09/06/2000SE |
| K993071 | Puritan-Bennett Ventilator System with Et/Tracheostomy Tube Compensation, TC, Option…CBK · Special | 11/24/1999ST |
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | 10/22/1999SE |
| K993088 | Puritan-Bennett Aeris 590 Oxygen Concentrator with OciCAW · Special | 10/08/1999SE |
| K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel OptionCBK · Special | 12/28/1998ST |
Questions and answers
When was Ventilator with Respiratory Mechanics, Model 840 cleared by the FDA?
Ventilator with Respiratory Mechanics, Model 840 (K063650) received a 510(k) decision of Substantially Equivalent on February 15, 2007, 69 days after the submission was received.
What is the product code of K063650?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.