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862.2100—Calculator/data processing module for clinical use.
(a) Identification.
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
(b) Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Code of Federal Regulations
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