Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K093298 |
Device Name |
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
EUGENE VAN ARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE VAN ARSDALE |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 10/21/2009 |
Decision Date | 12/10/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|