21 CFR 890.1600
§ 890.1600 Intermittent pressure measurement system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 890.1600, § 890.1600 Intermittent pressure measurement system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91165
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Full text
(a) Identification. An intermittent pressure measurement system is an evaluative device intended for medical purposes, such as to measure the actual pressure between the body surface and the supporting media.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.