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FDA 510(k)

REUSABLE HEADREST WITH NASAL SEAL

K-Number: K072993 · 2008-02-08

ApplicantAeiomed, Inc.
Decision Date2008-02-08
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REUSABLE HEADREST WITH NASAL SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Aeiomed, Inc.. It received FDA 510(k) clearance on 2008-02-08 under 510(k) number K072993. 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 REUSABLE HEADREST WITH NASAL SEAL?

REUSABLE HEADREST WITH NASAL SEAL is a medical device that received FDA 510(k) clearance on 2008-02-08. The listed applicant is Aeiomed, Inc.. The 510(k) number is K072993.

When did REUSABLE HEADREST WITH NASAL SEAL receive FDA 510(k) clearance?

REUSABLE HEADREST WITH NASAL SEAL received FDA 510(k) clearance on 2008-02-08, under 510(k) number K072993.

Who is the listed applicant for REUSABLE HEADREST WITH NASAL SEAL?

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

What is the FDA product code for REUSABLE HEADREST WITH NASAL SEAL?

The FDA product code for REUSABLE HEADREST WITH NASAL SEAL is BZD.

Related Clinical Trials

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Other records listing Aeiomed, Inc. as applicant

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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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