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FDA 510(k)

EMS NASAL CPAP MASK

K-Number: K972605 · 1998-01-28

ApplicantEngineered Medical Systems
Decision Date1998-01-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EMS NASAL CPAP MASK is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Medical Systems. It received FDA 510(k) clearance on 1998-01-28 under 510(k) number K972605. 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 EMS NASAL CPAP MASK?

EMS NASAL CPAP MASK is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is Engineered Medical Systems. The 510(k) number is K972605.

When did EMS NASAL CPAP MASK receive FDA 510(k) clearance?

EMS NASAL CPAP MASK received FDA 510(k) clearance on 1998-01-28, under 510(k) number K972605.

Who is the listed applicant for EMS NASAL CPAP MASK?

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

What is the FDA product code for EMS NASAL CPAP MASK?

The FDA product code for EMS NASAL CPAP MASK 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 Engineered Medical Systems 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.

K023683MULTI-STRAP FULL FACE MASKK013728TRACH VOXK013122EMS ELECTROSTATIC FLITER AND HME COMBINATIONK013089EMS HEPA FILTER AND HME COMBINATIONSK013123EMS PULMONARY FUNCTION TESTING FILTERK003497DISPOSABLE PRESSURE MONITOR

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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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