K901301 is an FDA 510(k) clearance for the STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on May 31, 1990, 72 days after receiving the submission on March 20, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K901301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1990 |
| Decision Date | May 31, 1990 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |