K911399 is an FDA 510(k) clearance for the NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST). This device is classified as a Tube, Orthodontic (Class I - General Controls, product code DZD).
Submitted by Aequitron Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 19, 1991, 174 days after receiving the submission on March 29, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K911399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 1991 |
| Decision Date | September 19, 1991 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DZD — Tube, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |