K984407 is an FDA 510(k) clearance for the BIPAP HARMONY S/T, MODEL 1001445. This device is classified as a Ventilator, Continuous, Non-life-supporting (Class II - Special Controls, product code MNS).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on May 19, 1999, 161 days after receiving the submission on December 9, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5895.
| 510(k) Number | K984407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1998 |
| Decision Date | May 19, 1999 |
| Days to Decision | 161 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNS — Ventilator, Continuous, Non-life-supporting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5895 |