GroundRules
21 CFR 890.1615: Miniature pressure transducer.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 890—PHYSICAL MEDICINE DEVICES
- Subpart B—Physical Medicine Diagnostic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON