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FDA 510(k)

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT

K-Number: K012034 · 2001-07-24

ApplicantSensor Medics Corp.
Decision Date2001-07-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 2001-07-24 under 510(k) number K012034. 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: SIPAP INFANT NASAL CPAP CIRCUIT?

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT is a medical device that received FDA 510(k) clearance on 2001-07-24. The listed applicant is Sensor Medics Corp.. The 510(k) number is K012034.

When did MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT receive FDA 510(k) clearance?

MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT received FDA 510(k) clearance on 2001-07-24, under 510(k) number K012034.

Who is the listed applicant for MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT?

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

What is the FDA product code for MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT?

The FDA product code for MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT is BZD.

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Other records listing Sensor Medics Corp. 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.

K032516HIOX80 AEROSOL ADAPTERK031745INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONK031883LYRA NASAL MASKK030943MODIFICATION TO HIOXK022192PEGASUS NASAL CPAP SYSTEMK020665HI-OX

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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

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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