K915226 is an FDA 510(k) clearance for the ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT. 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 Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on January 12, 1993, 419 days after receiving the submission on November 20, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K915226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1991 |
| Decision Date | January 12, 1993 |
| Days to Decision | 419 days |
| Submission Type | Traditional |
| 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 |