The following data is part of a premarket notification filed by Keeler Limited with the FDA for Keeler Kapture Software.
| Device ID | K140450 |
| 510k Number | K140450 |
| Device Name: | KEELER KAPTURE SOFTWARE |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene Van Arsdale |
| Correspondent | Eugene Van Arsdale KEELER LIMITED 456 PARKWAY Broomall, PA 19008 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-24 |
| Decision Date | 2014-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272718035 | K140450 | 000 |
| 05055272718028 | K140450 | 000 |
| 05055272718011 | K140450 | 000 |
| 05055272718004 | K140450 | 000 |
| 05055272717991 | K140450 | 000 |
| 05055272715744 | K140450 | 000 |