Puritan-Bennett Companion 500 Liquid Oxygen System
FDA 510(k) K905530 · Puritan Bennett Corp.
510(k) numberK905530
Submission
- Device name
- Puritan-Bennett Companion 500 Liquid Oxygen System
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- December 10, 1990
- Decision date
- March 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BYT – Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5935
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K082657 | RTX RespiratorBYT · Traditional | Medivent Limited | 10/08/2008SE |
| K072290 | Pegaso V, Negavent Respirator, Model: DA-3 PlusBYT · Traditional | Dima Italia Srl | 05/29/2008SE |
| K924341 | Hayek Oscillator(Tm)BYT · Traditional | Respironics, Inc. | 07/21/1993SE |
| K910947 | NEV-10 Negative Pressure VentilatorBYT · Traditional | Lifecare Services, Inc. | 06/03/1991SE |
| K902764 | Emerson 33-AN Negative Pressure Respirator AlarmBYT · Traditional | J. H. Emerson Co. | 11/19/1990SE |
| K903745 | The Hayek OscillatorBYT · Traditional | Flexco Medical Instruments | 11/09/1990SE |
| K902300 | Easy Breather Model 100 AccessoriesBYT · Traditional | Progressive Productions , Ltd. | 07/19/1990SE |
| K895849 | Respironics Vacuvest Respiratory Support SystemBYT · Traditional | Respironics, Inc. | 12/22/1989SE |
| K894649 | Emerson 33-CR Chest RespiratorBYT · Traditional | Emerson Intl. Co. | 10/13/1989SE |
| K893213 | Easy Breather Model 100BYT · Traditional | Progressive Productions , Ltd. | 08/04/1989SE |
More from Progressive Productions , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K063650 | Ventilator with Respiratory Mechanics, Model 840CBK · Special | 02/15/2007SE |
| 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 |
Questions and answers
When was Puritan-Bennett Companion 500 Liquid Oxygen System cleared by the FDA?
Puritan-Bennett Companion 500 Liquid Oxygen System (K905530) received a 510(k) decision of Substantially Equivalent on March 1, 1991, 81 days after the submission was received.
What is the product code of K905530?
The FDA product code is BYT – Ventilator, External Body, Negative Pressure, Adult (Cuirass), a Class II (moderate risk) device regulated under 21 CFR 868.5935.