The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Hmef 500.
| Device ID | K021265 |
| 510k Number | K021265 |
| Device Name: | DATEX-OHMEDA HMEF 500 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2002-08-30 |
| Summary: | summary |