Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K984468 |
Device Name |
VITAL PEP |
Applicant |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Applicant Contact |
ANTHONY P MARTINO |
Correspondent |
VITAL SIGNS, INC. |
20 CAMPUS RD. |
TOTOWA,
NJ
07512
|
|
Correspondent Contact |
ANTHONY P MARTINO |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 12/16/1998 |
Decision Date | 06/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|