FDA 510(k)

NASAL-AIR CRITICAL CARE

K-Number: K031896 · 2004-01-14

Decision Date2004-01-14

Product CodeMNS

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

NASAL-AIR CRITICAL CARE is the device name listed in this FDA 510(k) record. The listed applicant is Innomed Technologies. It received FDA 510(k) clearance on 2004-01-14 under 510(k) number K031896. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL-AIR CRITICAL CARE?

NASAL-AIR CRITICAL CARE is a medical device that received FDA 510(k) clearance on 2004-01-14. The listed applicant is Innomed Technologies. The 510(k) number is K031896.

When did NASAL-AIR CRITICAL CARE receive FDA 510(k) clearance?

NASAL-AIR CRITICAL CARE received FDA 510(k) clearance on 2004-01-14, under 510(k) number K031896.

Who is the listed applicant for NASAL-AIR CRITICAL CARE?

The FDA 510(k) record lists Innomed Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL-AIR CRITICAL CARE?

The FDA product code for NASAL-AIR CRITICAL CARE is MNS. This falls under the Neurology category.

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Other records listing Innomed Technologies as applicant

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Official Source

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