Regulation Text
(a) Identification. A calculator/data processing module for clinical use is an electronic device intended to 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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.