K946209 is an FDA 510(k) clearance for the DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME. This device is classified as a Condenser, Heat And Moisture (artificial Nose) (Class I - General Controls, product code BYD).
Submitted by Med-Plastics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 8, 1995, 169 days after receiving the submission on December 21, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5375.
| 510(k) Number | K946209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1994 |
| Decision Date | June 08, 1995 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYD — Condenser, Heat And Moisture (artificial Nose) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5375 |