Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K172388 |
Device Name |
VPOD ITPR |
Applicant |
Advanced Circulatory System, a wholly owned subsidiary of |
ZOLL |
1905 County Rd C West |
Roseville,
MN
55113
|
|
Applicant Contact |
Anja Metzger |
Correspondent |
Advanced Circulatory System, a wholly owned subsidiary of |
ZOLL c/o ProMedic, LLC |
131 Bay Point Dr. NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul E. Dryden |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 08/08/2017 |
Decision Date | 12/22/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|