MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1

Device Classification Name

thermometer, electronic, clinical

510(k) Number K034023
Device Name MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern blvd., suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern blvd., suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 12/29/2003
Decision Date 01/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No