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FDA 510(k)

NEOPAP SYSTEM

K-Number: K103410 · 2011-03-30

ApplicantChildrens Medical Ventures, LLC
Decision Date2011-03-30
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEOPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Childrens Medical Ventures, LLC. It received FDA 510(k) clearance on 2011-03-30 under 510(k) number K103410. 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 NEOPAP SYSTEM?

NEOPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-30. The listed applicant is Childrens Medical Ventures, LLC. The 510(k) number is K103410.

When did NEOPAP SYSTEM receive FDA 510(k) clearance?

NEOPAP SYSTEM received FDA 510(k) clearance on 2011-03-30, under 510(k) number K103410.

Who is the listed applicant for NEOPAP SYSTEM?

The FDA 510(k) record lists Childrens Medical Ventures, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOPAP SYSTEM?

The FDA product code for NEOPAP SYSTEM is BZD.

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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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