MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2— 510(k) K033817
Substantially EquivalentMicrolife Intellectual Property GmbH
FDA 510(k) clearance K033817 for MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2, Substantially Equivalent on 2004-01-08. Applicant: Microlife Intellectual Property GmbH. Device class: 2.
Clearance details
- Applicant
- Microlife Intellectual Property GmbH
- 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
- Special
- Location
- Great Neck, NY, US
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More clearances from Microlife Intellectual Property GmbH
view all- K230075 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
- K222979 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
- K222153 — Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR)
- K211776 — Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)
- K211288 — Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
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.