Companion Mini Oxygen Saver
FDA 510(k) K873901 · Puritan Bennett Corp.
510(k) numberK873901
Submission
- Device name
- Companion Mini Oxygen Saver
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- September 24, 1987
- Decision date
- December 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
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| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
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| 510(k) | Device | Decision |
|---|---|---|
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| 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 Companion Mini Oxygen Saver cleared by the FDA?
Companion Mini Oxygen Saver (K873901) received a 510(k) decision of Substantially Equivalent on December 2, 1987, 69 days after the submission was received.
What is the product code of K873901?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.