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FDA 510(k)

O_TWO CPAP SYSTEM

K-Number: K112546 · 2011-12-27

ApplicantO-Two Medical Technologies, Inc.
Decision Date2011-12-27
Product CodeBYE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

O_TWO CPAP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Medical Technologies, Inc.. It received FDA 510(k) clearance on 2011-12-27 under 510(k) number K112546. The device is classified under product code BYE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O_TWO CPAP SYSTEM?

O_TWO CPAP SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-27. The listed applicant is O-Two Medical Technologies, Inc.. The 510(k) number is K112546.

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

O_TWO CPAP SYSTEM received FDA 510(k) clearance on 2011-12-27, under 510(k) number K112546.

Who is the listed applicant for O_TWO CPAP SYSTEM?

The FDA 510(k) record lists O-Two Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O_TWO CPAP SYSTEM?

The FDA product code for O_TWO CPAP SYSTEM is BYE.

Related Clinical Trials

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Other records listing O-Two Medical Technologies, 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.

K173205Equinox AdvantageK113687EQUINOX RELIEVEK093862CAREVENT HANDHELD CPAP SYSTEMK081330CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)K051469CAREVENT ATV+ AND CAREVENT MRIK051889CAREVENT CA AND DRA

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Related Devices (Code: BYE)

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.

K160112Besmed PEEP ValveBesmed Health Business CorpK122610PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIESSen MU Technology Co., Ltd.K110713WATERPAP VALVEAirways Development, LLCK103833NEOPIP PATIENT CIRCUIT WITH PEEPNeoforce Group, Inc.K092029VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310Draeger Medical AG & Co. KGK090710MERCURY CPAPMercury Medical

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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