The following data is part of a premarket notification filed by Sonometrics Systems, Inc. with the FDA for Glaukon.
Device ID | K820751 |
510k Number | K820751 |
Device Name: | GLAUKON |
Classification | Tonometer, Ac-powered |
Applicant | SONOMETRICS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HKX |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-19 |
Decision Date | 1982-04-09 |