K881970 is an FDA 510(k) clearance for the MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on March 9, 1989, 302 days after receiving the submission on May 11, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K881970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 1988 |
| Decision Date | March 09, 1989 |
| Days to Decision | 302 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |