Atlas FDA

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1

FDA 510(k) clearance K003308 · decided 2000-11-14

Clearance details

K-number
K003308
Device name
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
Applicant
Microlife Corp.
Decision
Substantially Equivalent
Date received
2000-10-23
Decision date
2000-11-14
Days to decision
22 days
Clearance type
Special
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.