Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K041309 |
Device Name |
IMASK TM |
Applicant |
VITAL SIGNS, INC. |
11039 EAST LANSING CIRCLE |
ENGLEWOOD,
CO
|
|
Applicant Contact |
THOMAS DIELMANN |
Correspondent |
VITAL SIGNS, INC. |
11039 EAST LANSING CIRCLE |
ENGLEWOOD,
CO
|
|
Correspondent Contact |
THOMAS DIELMANN |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 05/17/2004 |
Decision Date | 06/30/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|