K962492 is an FDA 510(k) clearance for the SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on January 23, 1997, 211 days after receiving the submission on June 26, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K962492 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1996 |
| Decision Date | January 23, 1997 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYE - Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5965 |