FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
K Number: K891008
·
Decision May 31, 1989
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
21
Applicant Total
5
Review Days
89
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Basic Information
- Device Name
- VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
- K Number
- K891008
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Micromedical Technologies, Inc.
- Date Received
- March 3, 1989
- Decision Date
- May 31, 1989
- Product Code
- LXV
- Advisory Committee
- Unknown
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXV | Apparatus, Vestibular Analysis | FDA unclassified | Unknown |
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Other Clearances by Micromedical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964646 | VIDEO EYE TRAKKER | Jul 15, 1997 | Substantially Equivalent |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | Jul 15, 1997 | Substantially Equivalent |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | Oct 26, 1992 | Substantially Equivalent |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | Mar 23, 1987 | Substantially Equivalent |