The following data is part of a premarket notification filed by Koi, Inc. with the FDA for Koi Pachymeter.
| Device ID | K843247 |
| 510k Number | K843247 |
| Device Name: | KOI PACHYMETER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | KOI, INC. TWO DAVIS AVENUE Frazer , PA 19355 - |
| Contact | W. R Knepshield |
| Correspondent | W. R Knepshield KOI, INC. TWO DAVIS AVENUE Frazer , PA 19355 - |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1986-04-30 |