Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K121374 |
Device Name |
ZI BLOWER |
Applicant |
DESHUM MEDICAL |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Applicant Contact |
MAUREEN O'CONNELL |
Correspondent |
DESHUM MEDICAL |
5 TIMBER LANE |
NORTH READING,
MA
01864
|
|
Correspondent Contact |
MAUREEN O'CONNELL |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 05/07/2012 |
Decision Date | 02/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|