Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K042245 |
Device Name |
VAPOTHERM MODEL#2000I, 200H |
Applicant |
VAPOTHERM, INC. |
6329 W.WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
VAPOTHERM, INC. |
6329 W.WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 08/19/2004 |
Decision Date | 08/30/2004 |
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
|
|
|