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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 a medical device manufactured by Caire Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-06-07 under approval 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. It is manufactured by Caire Diagnostics, Inc.. The 510(k) number is K213611.

When was Fenom Pro approved by the FDA?

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

What company makes Fenom Pro?

Fenom Pro is manufactured by Caire Diagnostics, Inc..

What is the FDA product code for Fenom Pro?

The FDA product code for Fenom Pro is MXA.

Related Devices (Code: MXA)

K170983NIOX VEROCircassia AB K182874Fenom Pro Nitric Oxide TestSpirosure, Inc. K203695NObreath®Bedfont Scientific, Ltd. K233775Vivatmo proBosch Healthcare Solutions GmbH K251674Fenom Flo™ FeNO Monitoring SystemMgc Diagnostics Corporation K243926Vivatmo pro-SBosch Healthcare Solutions GmbH

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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