Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K072845 |
FOIA Releasable 510(k) |
K072845
|
Device Name |
PRECISION FLOW |
Applicant |
VAPOTHERM, INC. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
21666
|
|
Applicant Contact |
JONATHAN S KAHN |
Correspondent |
VAPOTHERM, INC. |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
21666
|
|
Correspondent Contact |
JONATHAN S KAHN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 10/04/2007 |
Decision Date | 07/17/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|