The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Tonometry Module, E Tono And Accessories.
| Device ID | K052167 |
| 510k Number | K052167 |
| Device Name: | DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C 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 | 2005-08-09 |
| Decision Date | 2005-09-08 |
| Summary: | summary |