Cyl-Fil Oxygen System
FDA 510(k) K061785 · Responsive Respiratory, Inc.
510(k) numberK061785
Submission
- Device name
- Cyl-Fil Oxygen System
- Applicant
- Responsive Respiratory, Inc.
St. Louis, MO, US - Received
- June 23, 2006
- Decision date
- September 7, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAN – Regulator, Pressure, Gas Cylinder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2700
- Specialty
- Anesthesiology
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| K060265 | Remcore Remote Controlled Oxygen RegulatorCAN · Traditional | Remcore, Inc. | 10/25/2006SE |
| 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 |
| K915505 | Regulator FlowmeterCAN · Traditional | Lifeguard Medical Products, Inc. | 04/22/1992SE |
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Questions and answers
When was Cyl-Fil Oxygen System cleared by the FDA?
Cyl-Fil Oxygen System (K061785) received a 510(k) decision of Substantially Equivalent on September 7, 2006, 76 days after the submission was received.
What is the product code of K061785?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.