The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 E-psm(p) Module (consisting Of E-psm, E-psmp And E-intpsm Modules) And Accessories.
| Device ID | K062576 |
| 510k Number | K062576 |
| Device Name: | DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2006-09-29 |
| Summary: | summary |