The following data is part of a premarket notification filed by Optical Radiation Corp. with the FDA for Computon(r).
| Device ID | K863200 |
| 510k Number | K863200 |
| Device Name: | COMPUTON(R) |
| Classification | Tonometer, Ac-powered |
| Applicant | OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Contact | Charmaine Henderson |
| Correspondent | Charmaine Henderson OPTICAL RADIATION CORP. 1300 OPTICAL DR. Azusa, CA 91702 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-09-03 |