21 CFR 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]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.