Device Classification Name |
mask, oxygen, non-rebreathing
|
510(k) Number |
K932347 |
Device Name |
COMPACT MASK |
Applicant |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Applicant Contact |
CHARLES KLEIN |
Correspondent |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Correspondent Contact |
CHARLES KLEIN |
Regulation Number | 868.5570
|
Classification Product Code |
|
Date Received | 05/14/1993 |
Decision Date | 01/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|