Demand Oxygen Controller
FDA 510(k) K833351 · Healthdyne, Inc.
510(k) numberK833351
Submission
- Device name
- Demand Oxygen Controller
- Applicant
- Healthdyne, Inc.
Walker, MI, US - Received
- September 28, 1983
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZB – Catheter, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5350
- Specialty
- Anesthesiology
Other 510(k)s with product code BZB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896731 | Oxygen CathetersBZB · Traditional | Unoplast A/S | 03/30/1990SE |
| K843466 | Pharma-Plast Oxygen CatheterBZB · Traditional | Zimmar Consulting , Ltd. | 11/19/1984SE |
| K830984 | Oxygen CathetersBZB · Traditional | Medovations, Inc. | 05/18/1983SE |
| K820370 | Nasal Oxygen CatheterBZB · Traditional | American Pharmaseal Div. Ahsc | 04/16/1982SE |
| K800506 | Oxygen CatheterBZB · Traditional | Medi-Craft , Ltd. | 03/25/1980SE |
| K791273 | Conphar Oxygen Catheter-SterileBZB · Traditional | Conphar, Inc. | 07/24/1979SE |
| K790057 | Catheter, OxygenBZB · Traditional | Medline Industries, Inc. | 02/05/1979SE |
More from Medline Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950331 | Pressure Support Ventilatory Assist System (Psvas)BZD · Traditional | 09/21/1995SE |
| K922106 | AliceOLV · Traditional | 07/06/1994SE |
| K942357 | H-500 Alliance Oxygen ConcentratorCAW · Traditional | 05/27/1994SE |
| K934502 | Flow SpirometerBZH · Traditional | 04/04/1994SE |
| K924146 | OH-500 Oxygen ConcentratorCAW · Traditional | 01/07/1993SE |
| K922623 | Nebulizer SystemBTI · Traditional | 12/01/1992SE |
| K910118 | Data RecorderFLL · Traditional | 02/14/1991SE |
| K903287 | Model 900S Apnea/Heart MonitorBZQ · Traditional | 08/17/1990SE |
| K894030 | Model 37 Uterine Contraction Activity MonitorHFM · Traditional | 01/22/1990SE |
| K892006 | Healthdyne's Apnea/Heart Monitor, Model 900SDRT · Traditional | 05/23/1989SE |
Questions and answers
When was Demand Oxygen Controller cleared by the FDA?
Demand Oxygen Controller (K833351) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 173 days after the submission was received.
What is the product code of K833351?
The FDA product code is BZB – Catheter, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5350.