Device Classification Name |
Continuous Measurement Thermometer
|
510(k) Number |
K981456 |
Device Name |
BABY PACIFIER DIGITAL THERMOMETER |
Applicant |
K-JUMP HEALTH CO., LTD. |
581 CONFERENCE PLACE |
GOLDEN,
CO
80401
|
|
Applicant Contact |
ROBERT J ZAPPA |
Correspondent |
K-JUMP HEALTH CO., LTD. |
581 CONFERENCE PLACE |
GOLDEN,
CO
80401
|
|
Correspondent Contact |
ROBERT J ZAPPA |
Regulation Number | 880.2910 |
Classification Product Code |
|
Date Received | 04/23/1998 |
Decision Date | 07/02/1998 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|