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FDA 510(k)

Fenom Pro

K-Number: K213611 · 2023-06-07

ApplicantCaire Diagnostics, Inc.
Decision Date2023-06-07
Product CodeMXA
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Fenom Pro is the device name listed in this FDA 510(k) record. The listed applicant is Caire Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K213611. The device is classified under product code MXA. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fenom Pro?

Fenom Pro is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Caire Diagnostics, Inc.. The 510(k) number is K213611.

When did Fenom Pro receive FDA 510(k) clearance?

Fenom Pro received FDA 510(k) clearance on 2023-06-07, under 510(k) number K213611.

Who is the listed applicant for Fenom Pro?

The FDA 510(k) record lists Caire Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fenom Pro?

The FDA product code for Fenom Pro is MXA.

Related Devices (Code: MXA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics CorporationK243926Vivatmo pro-SBosch Healthcare Solutions GmbHK233775Vivatmo proBosch Healthcare Solutions GmbHK203695NObreath®Bedfont Scientific, Ltd.K182874Fenom Pro Nitric Oxide TestSpirosure, Inc.K170983NIOX VEROCircassia AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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