The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Neuromuscular Transmission Module, E-nmt And Accessories.
| Device ID | K051635 |
| 510k Number | K051635 |
| Device Name: | DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| 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 | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-20 |
| Decision Date | 2005-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104012 | K051635 | 000 |
| 00840682103633 | K051635 | 000 |
| 00840682103510 | K051635 | 000 |
| 00840682103503 | K051635 | 000 |
| 00840682103497 | K051635 | 000 |
| 00840682103480 | K051635 | 000 |
| 00840682103459 | K051635 | 000 |