1 device · 1 company · 2025
Product code PPW: Adjunctive Cardiovascular Status Indicator
1 device under product code PPW, 2025, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Adjunctive Cardiovascular Status Indicator. 21 CFR 870.2200, Class II. The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| prolaio eVO2peak ModuleK252204 · 510(k) | Prolaio, Inc. | Cardiovascular | database entry |
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