The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Nihon Kohden Vital Sign Telemeter.
| Device ID | K163459 |
| 510k Number | K163459 |
| Device Name: | Nihon Kohden Vital Sign Telemeter |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo, JP 161-8560 |
| Contact | Tom Bento |
| Correspondent | Tom Bento Nihon Kohden America, Inc. 15353 Barranca Parkway Irvine, CA 92618 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-09 |
| Decision Date | 2017-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14931921903527 | K163459 | 000 |
| 14931921881269 | K163459 | 000 |
| 14931921881245 | K163459 | 000 |
| 04931921903346 | K163459 | 000 |
| 04931921903315 | K163459 | 000 |
| 04931921903308 | K163459 | 000 |
| 04931921898406 | K163459 | 000 |
| 04931921898390 | K163459 | 000 |
| 04931921128244 | K163459 | 000 |
| 00841983104336 | K163459 | 000 |
| 00841983104237 | K163459 | 000 |
| 14931921882549 | K163459 | 000 |
| 14931921882563 | K163459 | 000 |
| 14931921903510 | K163459 | 000 |
| 14931921903503 | K163459 | 000 |
| 14931921903497 | K163459 | 000 |
| 14931921903480 | K163459 | 000 |
| 14931921903473 | K163459 | 000 |
| 14931921898359 | K163459 | 000 |
| 14931921882648 | K163459 | 000 |
| 14931921882624 | K163459 | 000 |
| 14931921882600 | K163459 | 000 |
| 14931921882587 | K163459 | 000 |
| 00841983104190 | K163459 | 000 |