The following data is part of a premarket notification filed by Responsive Respiratory Inc. with the FDA for Cyl-fil Oxygen System.
| Device ID | K061785 |
| 510k Number | K061785 |
| Device Name: | CYL-FIL OXYGEN SYSTEM |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | RESPONSIVE RESPIRATORY INC. 261 WOLFNER DRIVE Fenton, MO 63026 |
| Contact | Thomas Bannon |
| Correspondent | Thomas Bannon RESPONSIVE RESPIRATORY INC. 261 WOLFNER DRIVE Fenton, MO 63026 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-23 |
| Decision Date | 2006-09-07 |
| Summary: | summary |