Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K193621 |
Device Name |
Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) |
Applicant |
Dongguan E-Test Technology Co., Ltd |
Room 201, 301. Building 1, Changping Section No.1, |
Dongshen Road |
Dongguan,
CN
523588
|
|
Applicant Contact |
Victor Wan |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou |
Science Park |
Guangzhou,
CN
510000
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 12/26/2019 |
Decision Date | 11/23/2020 |
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
|
|
|