Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K071915 |
Device Name |
CPAP MASK |
Applicant |
ARCIMED LABORATORIES LLC |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ARCIMED LABORATORIES LLC |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/11/2007 |
Decision Date | 05/14/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|