Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K102831 |
Device Name |
RSI 4200 |
Applicant |
REIMERS SYSTEMS, INC. |
8210-D CINDERBED RD. |
LORTON,
VA
22079
|
|
Applicant Contact |
NAYIL ALAM |
Correspondent |
REIMERS SYSTEMS, INC. |
8210-D CINDERBED RD. |
LORTON,
VA
22079
|
|
Correspondent Contact |
NAYIL ALAM |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 09/29/2010 |
Decision Date | 08/19/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|