The following data is part of a premarket notification filed by Eyetech, Llc. with the FDA for Episcleral Venous Pressure.
Device ID | K843354 |
510k Number | K843354 |
Device Name: | EPISCLERAL VENOUS PRESSURE |
Classification | Tonometer, Ac-powered |
Applicant | EYETECH, LLC. 2042 W. FARRAGUT AVENUE Chicago , IL 60625 - |
Contact | Marek T Mori |
Correspondent | Marek T Mori EYETECH, LLC. 2042 W. FARRAGUT AVENUE Chicago , IL 60625 - |
Product Code | HKX |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-27 |
Decision Date | 1984-11-19 |