K030990 is an FDA 510(k) clearance for the DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR. This device is classified as a Filter, Bacterial, Breathing-circuit (Class II - Special Controls, product code CAH).
Submitted by Datex-Ohmeda (Needham, US). The FDA issued a Cleared decision on June 25, 2003, 89 days after receiving the submission on March 28, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K030990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2003 |
| Decision Date | June 25, 2003 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | CAH — Filter, Bacterial, Breathing-circuit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5260 |