Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K130686 |
Device Name |
NASAL COMFORT FREEDOM |
Applicant |
LAKEVIEW SLEEP CENTER |
400 NORTH RAND RD |
NORTH BARRINGTON,
IL
60010
|
|
Applicant Contact |
ANDY BLACK |
Correspondent |
LAKEVIEW SLEEP CENTER |
400 NORTH RAND RD |
NORTH BARRINGTON,
IL
60010
|
|
Correspondent Contact |
ANDY BLACK |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 03/13/2013 |
Decision Date | 10/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|