Devilbiss Model 1400D (Oxygen Conserving Device)
FDA 510(k) K890141 · Devilbiss Health Care, Inc.
510(k) numberK890141
Submission
- Device name
- Devilbiss Model 1400D (Oxygen Conserving Device)
- Applicant
- Devilbiss Health Care, Inc.
Somerset, PA, US - Received
- January 13, 1989
- Decision date
- April 6, 1989
- 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
Other 510(k)s with product code NFB
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|---|---|---|---|
| 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 |
|---|---|---|
| K963349 | Devilbiss 8650DBTI · Traditional | 06/13/1997SE |
| K970289 | Compressor/Nebulizer #3650CAF · Traditional | 04/15/1997SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | 10/21/1996SE |
| K950849 | Model #7354BZD · Traditional | 02/08/1996SE |
| K952491 | Model 7355BZD · Traditional | 01/31/1996SE |
| K952249 | Jet NebulizerCAF · Traditional | 01/30/1996SE |
| K953815 | 5 LPM Oxygen ConcentratorCAW · Traditional | 11/09/1995SE |
| K952037 | 3 LPM Oxygen ConcentratorCAW · Traditional | 09/06/1995SE |
| K946095 | Devilbiss Model 5500CAF · Traditional | 08/24/1995SE |
| K944611 | Model# 7500 SurveyorMNR · Traditional | 04/21/1995SE |
Questions and answers
When was Devilbiss Model 1400D (Oxygen Conserving Device) cleared by the FDA?
Devilbiss Model 1400D (Oxygen Conserving Device) (K890141) received a 510(k) decision of Substantially Equivalent on April 6, 1989, 83 days after the submission was received.
What is the product code of K890141?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.