Easy Pulse II Oxygen Conserver
FDA 510(k) K032018 · Precision Medical, Inc.
510(k) numberK032018
Submission
- Device name
- Easy Pulse II Oxygen Conserver
- Applicant
- Precision Medical, Inc.
Northampton, PA, US - Received
- June 30, 2003
- Decision date
- August 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code NFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800)NFB · Traditional | Responsive Respiratory | 07/24/2025SE |
| K220591 | ProximaNFB · Traditional | Dynasthetics, LLC | 12/15/2022SE |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional | Effortless Oxygen, LLC | 10/17/2022SE |
| K200401 | ApogeeNFB · Traditional | Incoba Ltd D/B/A Dynaris | 11/14/2020SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | Salter Labs | 03/11/2016SE |
| K131023 | Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional | Medical Products, LLC | 10/11/2013SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | Inovo, Inc. | 12/17/2010SE |
| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
More from Chad Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | 05/02/2018SE |
| K140179 | Easy Go VacBTA · Special | 04/25/2014SE |
| K103563 | Precision Portable Oxygen Concentration Model 4150CAW · Traditional | 07/01/2011SE |
| K103324 | Precision Liquid Oxygen SystemBYJ · Traditional | 04/21/2011SE |
| K090781 | HELIO2 BlenderBZR · Traditional | 08/13/2009SE |
| K072348 | Precision Oxygen ConcentratorCAW · Abbreviated | 10/27/2008SE |
| K063096 | Precision Oxygen MonitorCCL · Abbreviated | 02/27/2007SE |
| K053232 | Precision BlenderBZR · Traditional | 01/10/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | 12/09/2005SE |
| K041122 | Precision Liquid Oxygen SystemBYJ · Traditional | 10/04/2004SE |
Questions and answers
When was Easy Pulse II Oxygen Conserver cleared by the FDA?
Easy Pulse II Oxygen Conserver (K032018) received a 510(k) decision of Substantially Equivalent on August 25, 2003, 56 days after the submission was received.
What is the product code of K032018?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.