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FDA 510(k)

MODIFICATION TO NASAL-AIRE

K-Number: K022465 · 2003-03-21

ApplicantInnomed Technologies
Decision Date2003-03-21
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NASAL-AIRE is the device name listed in this FDA 510(k) record. The listed applicant is Innomed Technologies. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K022465. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO NASAL-AIRE?

MODIFICATION TO NASAL-AIRE is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Innomed Technologies. The 510(k) number is K022465.

When did MODIFICATION TO NASAL-AIRE receive FDA 510(k) clearance?

MODIFICATION TO NASAL-AIRE received FDA 510(k) clearance on 2003-03-21, under 510(k) number K022465.

Who is the listed applicant for MODIFICATION TO NASAL-AIRE?

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 MODIFICATION TO NASAL-AIRE?

The FDA product code for MODIFICATION TO NASAL-AIRE is BZD.

Related Clinical Trials

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.

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Other records listing Innomed Technologies as applicant

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.

K050171IT NASAL MASKK031896NASAL-AIR CRITICAL CARE

Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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.

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