JASUN, MODELS DT-01F AND DT-11F— 510(k) K030361
Substantially EquivalentHangzhou Hua'An Medical & Health Instruments Co.,
FDA 510(k) clearance K030361 for JASUN, MODELS DT-01F AND DT-11F, Substantially Equivalent on 2003-02-21. Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,. Device class: 2.
Clearance details
- Applicant
- Hangzhou Hua'An Medical & Health Instruments Co.,
- 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
- Barrington, IL, US
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- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
More clearances from Hangzhou Hua'An Medical & Health Instruments Co.,
view all- K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
- K092447 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
- K092514 — UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
- K041693 — WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
- K041692 — INFRARED EAR THERMOMETER, ET-100 SERIES
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.