Device Classification Name |
humidifier, respiratory gas, (direct patient interface)
|
510(k) Number |
K060790 |
Device Name |
BREAS, MODEL HA01 |
Applicant |
BREAS MEDICAL AB |
FORETAGSVAGEN 1 |
MOLNLYCKE,
SE
SE 435 33
|
|
Applicant Contact |
KARL-JOHAN HOLM |
Correspondent |
BREAS MEDICAL AB |
FORETAGSVAGEN 1 |
MOLNLYCKE,
SE
SE 435 33
|
|
Correspondent Contact |
KARL-JOHAN HOLM |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 03/23/2006 |
Decision Date | 05/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|