Who is the manufacturer of VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)?

Micromedical Technologies, Inc. filed the 510(k) submission for VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) (K891008).

What is the FDA product code for VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)?

LXV. as a Class U device in the EN panel.

What is the regulatory pathway for VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)

K891008 · Micromedical Technologies, Inc. · LXV · May 31, 1989 · EN

Device Facts

Record ID	K891008
Device Name	VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
Applicant	Micromedical Technologies, Inc.
Product Code	LXV · EN
Decision Date	May 31, 1989
Decision	SESE
Submission Type	Traditional
Device Class	Class U

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