K925217 is an FDA 510(k) clearance for the MERIDIAN MEDICAL SYSTEMS BREATHING FILTER. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Merit Medical Systems, Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 26, 1993, 102 days after receiving the submission on October 16, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K925217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 1992 |
| Decision Date | January 26, 1993 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |