Device Classification Name |
Chamber, Patient Isolation
|
510(k) Number |
K080117 |
Device Name |
PATIENT ISOLATION UNIT, MODEL G019-1000 |
Applicant |
GENTEX CORPORATION |
11525 SIXTH ST. |
RANCHO CUCAMONGA,
CA
91730
|
|
Applicant Contact |
BARRY SHOPE |
Correspondent |
GENTEX CORPORATION |
11525 SIXTH ST. |
RANCHO CUCAMONGA,
CA
91730
|
|
Correspondent Contact |
BARRY SHOPE |
Regulation Number | 880.5450
|
Classification Product Code |
|
Date Received | 01/17/2008 |
Decision Date | 01/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|