K040941 is an FDA 510(k) clearance for the CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES). This device is classified as a Ventilator, Non-continuous (respirator) (Class II - Special Controls, product code BZD).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on June 10, 2004, 59 days after receiving the submission on April 12, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5905.
| 510(k) Number | K040941 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2004 |
| Decision Date | June 10, 2004 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZD — Ventilator, Non-continuous (respirator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5905 |