The following data is part of a premarket notification filed by Kasha Software, Inc. with the FDA for Kasha Visual Field System.
Device ID | K971156 |
510k Number | K971156 |
Device Name: | KASHA VISUAL FIELD SYSTEM |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | KASHA SOFTWARE, INC. 1700 INTERFACE LAND #208 Charlotte, NC 28262 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-28 |
Decision Date | 1997-05-28 |