Micromedical Technologies, Inc.
Auburn, IL, US
Micromedical Technologies, Inc. appears in FDA device records in Auburn, IL. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Micromedical Technologies, Inc. between 1987 and 1997. The busiest year on record is 1997, with 2. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1989 | 1 |
| 1992 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964646 | VIDEO EYE TRAKKER | GWN | Substantially Equivalent | |
| K964325 | VISUALEYES: VIDEO EYE MONITOR | GWN | Substantially Equivalent | |
| K922037 | SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR | LXV | Substantially Equivalent | |
| K891008 | VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) | LXV | Substantially Equivalent | |
| K863424 | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE | GWN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0563-2010 | AquaStar Water Caloric Irrigator; water caloric stimulator; Manufactured for/Distributed by Micromedical Technologies, Inc., 10 Kemp Drive, Chatham, IL 62629 USA, Instrumentation Difra, Made in Belgium. The AquaStar water caloric irrigator delivers a precisely controlled temperature and flow rate of cool or warm water for vestibular stimulation during caloric testing. The caloric tests evaluate the viability of the horizontal semicircular canal by stimulating them with warm and cool water while the patient's eyes are closed. The resulting dizziness and nystagmus is taken as an index of the viability of the organ. The eyes are then opened to evaluate the ability of the CNS to visually suppress inappropriate dizziness and nystagmus. | Some of the filters on both the display board and the main electronic board (PCB) become oxidized causing the LCD display to be garbled and the timer will not operate. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain