Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K033818 |
Device Name |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290 |
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
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 12/09/2003 |
Decision Date | 01/08/2004 |
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
|
|
|