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FDA 510(k)

MODEL 300157 CPAP SYSTEM

K-Number: K100121 · 2010-07-13

ApplicantAeiomed, Inc.
Decision Date2010-07-13
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 300157 CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aeiomed, Inc.. It received FDA 510(k) clearance on 2010-07-13 under 510(k) number K100121. 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 MODEL 300157 CPAP SYSTEM?

MODEL 300157 CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Aeiomed, Inc.. The 510(k) number is K100121.

When did MODEL 300157 CPAP SYSTEM receive FDA 510(k) clearance?

MODEL 300157 CPAP SYSTEM received FDA 510(k) clearance on 2010-07-13, under 510(k) number K100121.

Who is the listed applicant for MODEL 300157 CPAP SYSTEM?

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 MODEL 300157 CPAP SYSTEM?

The FDA product code for MODEL 300157 CPAP SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aeiomed, Inc. 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.

K072993REUSABLE HEADREST WITH NASAL SEALK042945AURA CPAP SYSTEMK042130AURA CPAP PATIENT INTERFACE

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

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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