K903519 is an FDA 510(k) clearance for the INTERTECH(TM) HEAT AND MOISTURE EXCHANGER. This device is classified as a Condenser, Heat And Moisture (artificial Nose) (Class I - General Controls, product code BYD).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on December 13, 1990, 132 days after receiving the submission on August 3, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5375.
| 510(k) Number | K903519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1990 |
| Decision Date | December 13, 1990 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYD — Condenser, Heat And Moisture (artificial Nose) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5375 |