GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE


Device Classification Name

thermometer, electronic, clinical

510(k) Number K121999
Device Name GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
Applicant
DRAEGER MEDICAL GMBH
6 tech dr
andover, 
MA 
01810

Applicant Contact beth zis
Correspondent
DRAEGER MEDICAL GMBH
6 tech dr
andover, 
MA 
01810

Correspodent Contact beth zis
Regulation Number 880.2910
Classification Product Code
FLL  
Date Received 07/09/2012
Decision Date 02/28/2013
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