FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY— 510(k) K100427
Substantially EquivalentTaidoc Technology Corporation
FDA 510(k) clearance K100427 for FORA GW 9014 TELEHEALTH GATEWAY/TD-9014 TELEHEALTH GATEWAY, Substantially Equivalent on 2010-05-28. Applicant: Taidoc Technology Corporation. Device class: 2.
Clearance details
- Applicant
- Taidoc Technology Corporation
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
Recent devices under product code DRG
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- K200946 — Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)
- K190579 — TD-4183 Blood Glucose Monitoring System
- K182934 — FORA P100 Blood Pressure Monitoring System
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.