The following data is part of a premarket notification filed by Retinapharma Technologies Inc. with the FDA for Tonopach Ultrasonic Tonometer/pachymeter Model P-201 (the Tonopach).
| Device ID | K042099 |
| 510k Number | K042099 |
| Device Name: | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) |
| Classification | Tonometer, Ac-powered |
| Applicant | RETINAPHARMA TECHNOLOGIES INC. 944 MORGAN ROAD Jenkintown, PA 19046 |
| Contact | Terry A Fuller, Ph.d. |
| Correspondent | Terry A Fuller, Ph.d. RETINAPHARMA TECHNOLOGIES INC. 944 MORGAN ROAD Jenkintown, PA 19046 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-04 |
| Decision Date | 2004-12-10 |
| Summary: | summary |