Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K111406 |
Device Name |
BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL) |
Applicant |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
NO. 8-1, LONGQUAN ROAD |
CANGQIAN TOWN, YUHANG DISTRICT |
HANGZHOU, ZHEJIANG,
CN
311121
|
|
Applicant Contact |
ALLYSON ZHOU |
Correspondent |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
NO. 8-1, LONGQUAN ROAD |
CANGQIAN TOWN, YUHANG DISTRICT |
HANGZHOU, ZHEJIANG,
CN
311121
|
|
Correspondent Contact |
ALLYSON ZHOU |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 05/19/2011 |
Decision Date | 07/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|