21 C.F.R. § 890.1615

Current through October 31, 2024
Section 890.1615 - Miniature pressure transducer
(a)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.
(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 § 890.9 .

21 C.F.R. §890.1615

48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816 , July 25, 2001