21 C.F.R. § 862.2100

Updated February 7, 2019
§ 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.

[52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001]