The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Conchapak Oxygen Diluter.
| Device ID | K780011 |
| 510k Number | K780011 |
| Device Name: | CONCHAPAK OXYGEN DILUTER |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | RESPIRATORY CARE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-03 |
| Decision Date | 1978-02-02 |