K962220 is an FDA 510(k) clearance for the HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER. 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 Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on January 14, 1997, 218 days after receiving the submission on June 10, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5270.
| 510(k) Number | K962220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1996 |
| Decision Date | January 14, 1997 |
| Days to Decision | 218 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 |