Device Classification Name |
bed, ac-powered adjustable hospital
|
510(k) Number |
K103536 |
Device Name |
IBED WIRELESS WITH IBED AWARENESS |
Applicant |
STRYKER CORPORATION |
3800 E. CENTRE AVE |
PORTAGE,
MI
49002
|
|
Applicant Contact |
Diane Horwitz |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
WILLIAM SAMMONS |
Regulation Number | 880.5100
|
Classification Product Code |
|
Date Received | 12/01/2010 |
Decision Date | 12/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|