MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
FDA 510(k) clearance K100953 · decided 2010-05-17
Clearance details
- K-number
- K100953
- Device name
- MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
- Applicant
- Microlife Intellectual Property GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-04-06
- Decision date
- 2010-05-17
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FLL
- Device class
- 2
- Regulation number
- 880.2910
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Great Neck, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.