Device Classification Name |
Mixer, Breathing Gases, Anesthesia Inhalation
|
510(k) Number |
K103317 |
Device Name |
RESUSCITATION UNIT 105 |
Applicant |
ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 11/10/2010 |
Decision Date | 04/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|