The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Telemetry Transmitter.
| Device ID | K161056 |
| 510k Number | K161056 |
| Device Name: | Telemetry Transmitter |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Edan Instruments, Inc. 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019# Shenzhen, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Doug Worth Edan Medical 1200 Crossman Way, Suite 200 Sunnyvale, CA 94089 |
| Product Code | MHX |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | GXY |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-14 |
| Decision Date | 2017-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413807075 | K161056 | 000 |
| 06944413803671 | K161056 | 000 |
| 06944413803688 | K161056 | 000 |
| 06944413803695 | K161056 | 000 |
| 06944413803701 | K161056 | 000 |
| 06944413803718 | K161056 | 000 |
| 06944413803725 | K161056 | 000 |
| 06944413803732 | K161056 | 000 |
| 06944413803749 | K161056 | 000 |
| 06944413802278 | K161056 | 000 |