Portable Gaseous Oxgyen Container
FDA 510(k) K852663 · Cryogenic Assoc.
510(k) numberK852663
Submission
- Device name
- Portable Gaseous Oxgyen Container
- Applicant
- Cryogenic Assoc.
Indianapolis, IN, US - Received
- June 24, 1985
- Decision date
- August 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAN – Regulator, Pressure, Gas Cylinder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2700
- Specialty
- Anesthesiology
Other 510(k)s with product code CAN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162811 | MR Conditional CGA 870CAN · Traditional | Essex Industries, Inc. | 03/02/2017SE |
| K080243 | Portable Oxygen Unit SCA900CAN · Traditional | San Cheong Co. , Ltd. | 04/07/2009SE |
| K060265 | Remcore Remote Controlled Oxygen RegulatorCAN · Traditional | Remcore, Inc. | 10/25/2006SE |
| K061785 | Cyl-Fil Oxygen SystemCAN · Traditional | Responsive Respiratory, Inc. | 09/07/2006SE |
| K950777 | Oxygen RegulatorCAN · Traditional | Mada Medical Products, Inc. | 04/14/1995SE |
| K942751 | Vanguard Series Gas RegulatorsCAN · Traditional | Buckman Co., Inc. | 02/09/1995SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | Life Support Products, Inc. | 01/27/1994SE |
| K932006 | 1500 Series RegulatorCAN · Traditional | Precision Medical, Inc. | 10/25/1993SE |
| K921125 | Ambu Oxygen RegulatorCAN · Traditional | Amg, LLC | 09/17/1992SE |
| K915154 | Gambro Engstrom Y Filter Pkg. Alone W/ Var.ModelsCAN · Traditional | C.G.H. Medical, Inc. | 05/27/1992SE |
More from C.G.H. Medical, Inc.
Questions and answers
When was Portable Gaseous Oxgyen Container cleared by the FDA?
Portable Gaseous Oxgyen Container (K852663) received a 510(k) decision of Substantially Equivalent on August 29, 1985, 66 days after the submission was received.
What is the product code of K852663?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.