Fenom Pro Nitric Oxide Test— 510(k) K182874

Substantially Equivalent

Spirosure, Inc.

FDA 510(k) clearance K182874 for Fenom Pro Nitric Oxide Test, Substantially Equivalent on 2019-02-13. Applicant: Spirosure, Inc.. Device class: 2.

Clearance details

Applicant: Spirosure, Inc.
Product code: Code MXA
Device class: Class 2
Regulation: 21 CFR 862.3080
Advisory panel: Clinical Toxicology
Date received: 2018-10-12
Decision date: 2019-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K182874

K-number listed on FDA's recall record

Z-1284-2021 — CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.Class II·Terminated·CAIRE DIAGNOSTICS INC·20210226

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K182874.

Data sourced from openFDA. This site is unofficial and independent of the FDA.