21 CFR 890.1600 — System, Pressure Measurement, Intermittent

Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1600

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
JFCSystem, Pressure Measurement, Intermittent111
Innolitics

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