Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)— 510(k) K193621
Substantially EquivalentDongguan E-Test Technology Co., Ltd.
FDA 510(k) clearance K193621 for Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318), Substantially Equivalent on 2020-11-23. Applicant: Dongguan E-Test Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Dongguan E-Test Technology Co., Ltd.
- Product code
- Code FLL
- Device class
- Class 2
- Regulation
- 21 CFR 880.2910
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan City, CN
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More clearances from Dongguan E-Test Technology Co., Ltd.
view all- K250231 — Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
- K193627 — Automatic Upper Arm Blood Pressure Monitor
- K193628 — AGE Automatic Wrist Blood Pressure Monitor
- K193624 — Automatic Upper Arm Blood Pressure Monitor
Adverse events under product code FLL
product code FLL- Death
- 3
- Malfunction
- 557
- Total
- 560
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.