The following data is part of a premarket notification filed by Keeler Ltd. with the FDA for D-kat Z-ype.
| Device ID | K142179 |
| 510k Number | K142179 |
| Device Name: | D-KAT Z-YPE |
| Classification | Tonometer, Manual |
| Applicant | KEELER LTD. 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene R Van Arsdale |
| Correspondent | Eugene R Van Arsdale KEELER LTD. 456 PARKWAY Broomall, PA 19008 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-08 |
| Decision Date | 2014-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272712217 | K142179 | 000 |