Device product
etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
Z-1461-2022
Product summary
- Firm
- Touch US Llc
- Event
- Event 90523
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 149
- Official record key
device-enforcement:Z-1461-2022
Official wording
Reason: Device was marketed without FDA 510(k) clearance or a PMA.
Code information: UDI-DI (GTIN): 00195893740581
Distribution pattern: US Nationwide Distribution to: CA, FL IL KY LA MA MD MI NC NH NJ NY OH OK OR PA TN TX VA
Derived failure modes
-
Unknown
Device was marketed without FDA 510(k) clearance or a PMA.