The following data is part of a premarket notification filed by Biosan Laboratories, Inc. with the FDA for Photron Visual Field Analyzer.
Device ID | K860642 |
510k Number | K860642 |
Device Name: | PHOTRON VISUAL FIELD ANALYZER |
Classification | Screen, Tangent, Ac-powered (campimeter) |
Applicant | BIOSAN LABORATORIES, INC. 1016 C ST. San Rafael, CA 94901 |
Contact | John Downing |
Correspondent | John Downing BIOSAN LABORATORIES, INC. 1016 C ST. San Rafael, CA 94901 |
Product Code | HOM |
CFR Regulation Number | 886.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-20 |
Decision Date | 1986-04-15 |