The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Single-width Airway Module M-minic And Accessories.
| Device ID | K023454 |
| 510k Number | K023454 |
| Device Name: | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE M-MINIC AND ACCESSORIES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2003-04-23 |
| Summary: | summary |