K952845 is an FDA 510(k) clearance for the HUMID-VENT TRACH-VENT. This device is classified as a Condenser, Heat And Moisture (artificial Nose) (Class I - General Controls, product code BYD).
Submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 25, 1995, 34 days after receiving the submission on June 21, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5375.
| 510(k) Number | K952845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1995 |
| Decision Date | July 25, 1995 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYD — Condenser, Heat And Moisture (artificial Nose) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5375 |