K993355 is an FDA 510(k) clearance for the HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43. This device is classified as a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II - Special Controls, product code BTT).
Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on May 24, 2000, 231 days after receiving the submission on October 6, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K993355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1999 |
| Decision Date | May 24, 2000 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |