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HAI CL-1000xyz clinical specular microscope
Hightech American Industrial Labs Inc · Model 1 · UDI-DI 00852194002014
1
510(k) clearances
0
Adverse events
2
Recalls
10
Facilities
Description
HAI CL-1000xyz is the clinical contact specular microscope. It evaluates the patient cornea endothelial cell layer. It is Class II, NQE medical device. In 2000, FDA notified that HAI CL-1000xyz received the 510(k) number K994340.
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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