The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Nellcor Compatible Saturation Module, E-nsat.
| Device ID | K052755 |
| 510k Number | K052755 |
| Device Name: | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104265 | K052755 | 000 |