The following data is part of a premarket notification filed by Med Air Technology, Inc. with the FDA for Variable High Flow Downs Cpap Generator.
| Device ID | K861104 |
| 510k Number | K861104 |
| Device Name: | VARIABLE HIGH FLOW DOWNS CPAP GENERATOR |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | MED AIR TECHNOLOGY, INC. 2519 E. KEARNEY Springfield, MO 65803 |
| Contact | Lois A Hansen |
| Correspondent | Lois A Hansen MED AIR TECHNOLOGY, INC. 2519 E. KEARNEY Springfield, MO 65803 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-24 |
| Decision Date | 1986-04-28 |