Clearance Summary
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 received FDA 510(k) clearance under submission number K034023, sponsored by Microlife Intellectual Property GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2004-01-15.
- Submission: K034023
- Applicant / Sponsor: Microlife Intellectual Property GmbH
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2004-01-15
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.