The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Nasal Cpap (continuous Positive Air Pressure Syst).
| Device ID | K911399 |
| 510k Number | K911399 |
| Device Name: | NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) |
| Classification | Tube, Orthodontic |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | DZD |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-09-19 |