Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K181143 |
Device Name |
Keeler TonoCare Tonometer |
Applicant |
Keeler Instruments Inc. |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Applicant Contact |
Eugene VanArsdale |
Correspondent |
Keeler Instruments Inc. |
3222 Phoenixville Pike |
Malvern,
PA
19355
|
|
Correspondent Contact |
Eugene VanArsdale |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 05/01/2018 |
Decision Date | 02/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|