Telemetry Transmitter
FDA 510(k) clearance K161056 · decided 2017-02-03
Clearance details
- K-number
- K161056
- Device name
- Telemetry Transmitter
- Applicant
- Edan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-04-14
- Decision date
- 2017-02-03
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product De recall (Z-1155-2026) | Edan Diagnostics | 2026-01-22 |
| EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is recall (Z-1256-2020) | Edan Diagnostics | 2020-02-18 |