K031653 is an FDA 510(k) clearance for the DATEX-OHMEDA HMEF 750. 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 20, 2003, 23 days after receiving the submission on May 28, 2003.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5260.
| 510(k) Number | K031653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2003 |
| Decision Date | June 20, 2003 |
| Days to Decision | 23 days |
| Submission Type | Special |
| 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 |