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EB-3000xyz
Hightech American Industrial Labs Inc · Model 1 · UDI-DI 00852194002007
9
510(k) clearances
0
Adverse events
2
Recalls
10
Facilities
Description
HAI EB-3000xyz is the non-contact eyebank specular microscope which is used to evaluate the endothelial cells layer for human cornea. HAI EB-3000xyz used same design as the Bio-Optic Inc ( an UA manufacturer) It considered the device substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. That do not require approval of a premarket approval (PMA). According to the letter from FDA from FDA on April. 26, 2004.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-25 | Nidek, Inc. | The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2) |
| 2016-08-08 | Nidek Inc | Software version 1.08 and 1.09 for the Specular Microscope CEM 530 included a change of analysis results feature that was not reviewed and approved by the FDA. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.