K980551 is an FDA 510(k) clearance for the SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM. This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on November 17, 1998, 278 days after receiving the submission on February 12, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K980551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1998 |
| Decision Date | November 17, 1998 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZD - Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |