K011134 is an FDA 510(k) clearance for the OXYGEN SUPPLY TUBING, MODEL 1115. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by Hudson Respiratory Care, Inc. (Temecula, US). The FDA issued a Cleared decision on June 13, 2001, 61 days after receiving the submission on April 13, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K011134 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2001 |
| Decision Date | June 13, 2001 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |