FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors— 510(k) K261714

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K261714 for FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors, Substantially Equivalent on 2026-10-27. Applicant: Transonic Systems, Inc.. Device class: 2.

Clearance details

Applicant
Transonic Systems, Inc.
Product code
Product code DPW
Device class
Class 2
Regulation
21 CFR 870.2100
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ithaca, NY, US
Download summary PDFView on FDA.gov ↗

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