K842988 is an FDA 510(k) clearance for the VMT GENTLE-HALER. This device is classified as a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I - General Controls, product code CCQ).
Submitted by Vortran Medical Technology 1, Inc. (Walker, US). The FDA issued a Cleared decision on August 7, 1984, 8 days after receiving the submission on July 30, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5640.
| 510(k) Number | K842988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 1984 |
| Decision Date | August 07, 1984 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | CCQ - Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5640 |