Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K932204 |
Device Name |
E-Z THERM 3 SECOND THERMOMETER |
Applicant |
NORTH AMERICAN TECHNICAL SERVICES CORP. |
30 NORTHPORT RD. |
SOUND BEACH,
NY
11789 -1734
|
|
Applicant Contact |
RICHARD LANZILLOTTO |
Correspondent |
NORTH AMERICAN TECHNICAL SERVICES CORP. |
30 NORTHPORT RD. |
SOUND BEACH,
NY
11789 -1734
|
|
Correspondent Contact |
RICHARD LANZILLOTTO |
Regulation Number | 880.2910 |
Classification Product Code |
|
Date Received | 05/06/1993 |
Decision Date | 10/03/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|