21 C.F.R. § 890.1615
Miniature pressure transducer.
Cite as 21 C.F.R. § 890.1615 (2026)
(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.
[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, 2001]
- Cross-references to the CFR
- 890.9.