§880.5420. Pressure infusor for an I.V. bag.
21 C.F.R. § 880.5420
Identification. A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.
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 § 880.9.
Notes, amendments, and revision history
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 69682, Oct. 21, 1980, unless otherwise noted.
Amendments
[45 FR 69682, Oct. 21, 1980, as amended at 65 FR 2318, Jan. 14, 2000]