The following data is part of a premarket notification filed by Nihon Kohden with the FDA for Netkonnect Remote Network Extension.
| Device ID | K112637 |
| 510k Number | K112637 |
| Device Name: | NETKONNECT REMOTE NETWORK EXTENSION |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | NIHON KOHDEN 90 ICON Foothill Ranch, CA 92610 |
| Contact | Steve Geerdes |
| Correspondent | Steve Geerdes NIHON KOHDEN 90 ICON Foothill Ranch, CA 92610 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2011-12-09 |
| Summary: | summary |