Device Classification Name |
Strap, Head, Gas Mask
|
510(k) Number |
K944949 |
Device Name |
GENERAL ANESTHESIA SYSTEM |
Applicant |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Applicant Contact |
JING ZHANG |
Correspondent |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Correspondent Contact |
JING ZHANG |
Regulation Number | 868.5560
|
Classification Product Code |
|
Date Received | 10/07/1994 |
Decision Date | 11/14/1994 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|