The following data is part of a premarket notification filed by Micromedical Technologies, Inc. with the FDA for Vestibular Ocular Reflex Test Equipment(vorteq).
Device ID | K891008 |
510k Number | K891008 |
Device Name: | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) |
Classification | Apparatus, Vestibular Analysis |
Applicant | MICROMEDICAL TECHNOLOGIES, INC. 110 WEST WALNUT Chatham, IL 62629 |
Contact | Richard Miles, Ph.d. |
Correspondent | Richard Miles, Ph.d. MICROMEDICAL TECHNOLOGIES, INC. 110 WEST WALNUT Chatham, IL 62629 |
Product Code | LXV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-03 |
Decision Date | 1989-05-31 |