MICROLIFE DIGITAL UNDERARM THERMOMETER


Device Classification Name

thermometer, electronic, clinical

510(k) Number K103680
Device Name MICROLIFE DIGITAL UNDERARM THERMOMETER
Applicant
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern boulevard
suite 200
great neck, 
NY 
10021

Applicant Contact susan d goldstein-falk
Correspondent
MICROLIFE INTELLECTUAL PROPERTY GMBH
55 northern boulevard
suite 200
great neck, 
NY 
10021

Correspodent Contact susan d goldstein-falk
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 12/17/2010
Decision Date 04/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No