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FDA 510(k)

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

K-Number: K120285 · 2012-07-02

ApplicantCurative Medical, Inc.
Decision Date2012-07-02
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER is the device name listed in this FDA 510(k) record. The listed applicant is Curative Medical, Inc.. It received FDA 510(k) clearance on 2012-07-02 under 510(k) number K120285. 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 K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER?

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER is a medical device that received FDA 510(k) clearance on 2012-07-02. The listed applicant is Curative Medical, Inc.. The 510(k) number is K120285.

When did K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER receive FDA 510(k) clearance?

K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER received FDA 510(k) clearance on 2012-07-02, under 510(k) number K120285.

Who is the listed applicant for K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER?

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

What is the FDA product code for K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER?

The FDA product code for K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER 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 Curative Medical, 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.

K131702K SERIES CPAP SYSTEMSK130663BESTFIT2 NASAL MASKK123897K SERIES CPAP SYSTEMS

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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