Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K090031 |
Device Name |
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 |
Applicant |
ACTHERM, INC. |
6F, NO.18 JHANYE 2ND RD., |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Applicant Contact |
RICHARD HSIEH |
Correspondent |
ACTHERM, INC. |
6F, NO.18 JHANYE 2ND RD., |
HSINCHU SCIENCE PARK |
HSINCHU,
TW
30078
|
|
Correspondent Contact |
RICHARD HSIEH |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 01/05/2009 |
Decision Date | 04/16/2009 |
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
|
|
|