21 CFR § 890.1615 - Miniature pressure transducer.
§ 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.