§890.1615. Miniature pressure transducer.
21 C.F.R. § 890.1615
Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.
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 § 890.9.
Notes, amendments, and revision history
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 48 FR 53047, Nov. 23, 1983, unless otherwise noted.
Amendments
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]