The following data is part of a premarket notification filed by Kera Corp. with the FDA for Videoscan (tm).
Device ID | K871479 |
510k Number | K871479 |
Device Name: | VIDEOSCAN (TM) |
Classification | Keratoscope, Ac-powered |
Applicant | KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
Contact | William B Collins |
Correspondent | William B Collins KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
Product Code | HLQ |
CFR Regulation Number | 886.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-14 |
Decision Date | 1987-05-22 |