The following data is part of a premarket notification filed by Universal Instruments Corp. with the FDA for Oftalmograf.
Device ID | K833024 |
510k Number | K833024 |
Device Name: | OFTALMOGRAF |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | UNIVERSAL INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-06 |
Decision Date | 1984-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OFTALMOGRAF 81030703 1030703 Dead/Cancelled |
Universal Initram Corporation 0000-00-00 |
OFTALMOGRAF 73666461 1487493 Dead/Cancelled |
MICHAEL, HENRY L. 1987-06-15 |