K791683 is an FDA 510(k) clearance for the STERILE WATER FOR RESPIRATORY THERAPY. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 17, 1979, 20 days after receiving the submission on August 28, 1979.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K791683 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1979 |
| Decision Date | September 17, 1979 |
| Days to Decision | 20 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 |