K110398 is an FDA 510(k) clearance for the RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS. This device is classified as a Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer (Class II - Special Controls, product code BZE).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on June 1, 2011, 110 days after receiving the submission on February 11, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K110398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2011 |
| Decision Date | June 01, 2011 |
| Days to Decision | 110 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZE — Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5270 |