The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Single-width Airway Module, E-minic And Accessories.
| Device ID | K052582 |
| 510k Number | K052582 |
| Device Name: | DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104043 | K052582 | 000 |