C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES › Subpart G—General Hospital and Personal Use Miscellaneous Devices

21 C.F.R. § 880.6320

AC-powered medical examination light

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(a) Identification. An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

(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 § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, 2001]
Notes of Decisions
Cited in 1 case, 1989–1989 · leading case: United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989).
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United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F. Supp. 1159 (D. Utah 1989). “For example, an AC-powered medical examination light, 21 C.F.R. § 880.6320 (1988); a battery-powered medical examination light, id.”
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