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 | K153707 |
| 510k Number | K153707 |
| 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 | 2015-12-23 |
| Decision Date | 2016-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14931921874308 | K153707 | 000 |
| 04931921117415 | K153707 | 000 |
| 04931921877432 | K153707 | 000 |
| 04931921902271 | K153707 | 000 |
| 04931921902295 | K153707 | 000 |
| 04931921902318 | K153707 | 000 |
| 04931921902332 | K153707 | 000 |
| 14931921829384 | K153707 | 000 |
| 14931921829421 | K153707 | 000 |
| 14931921863357 | K153707 | 000 |
| 14931921874261 | K153707 | 000 |
| 14931921874285 | K153707 | 000 |
| 04931921117392 | K153707 | 000 |