Device Classification Name |
Equipment, Traction, Powered
|
510(k) Number |
K043239 |
Device Name |
HEALTHSTAR ELITE |
Applicant |
HILL LABORATORIES CO. |
3 BACTON HILL RD. |
P.O. BOX 2028 |
FRAZER,
PA
19355
|
|
Applicant Contact |
HOWARD A HILL |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
MARC M MOUSER |
Regulation Number | 890.5900 |
Classification Product Code |
|
Date Received | 11/23/2004 |
Decision Date | 12/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|