Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K003308 |
Device Name |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 |
Applicant |
MICROLIFE CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
MICROLIFE CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 10/23/2000 |
Decision Date | 11/14/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|