K881231 is an FDA 510(k) clearance for the DABC NONCONDUCTIVE HEATED ANESTH. BREATH. 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 Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on July 1, 1988, 101 days after receiving the submission on March 22, 1988.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K881231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1988 |
| Decision Date | July 01, 1988 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| 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 |