K021265 is an FDA 510(k) clearance for the DATEX-OHMEDA HMEF 500. 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 August 30, 2002, 130 days after receiving the submission on April 22, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K021265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2002 |
| Decision Date | August 30, 2002 |
| Days to Decision | 130 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 |