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FDA 510(k)

MERLIN E-MASK

K-Number: K031397 · 2004-07-29

ApplicantMerlin Medical Limited
Decision Date2004-07-29
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MERLIN E-MASK is the device name listed in this FDA 510(k) record. The listed applicant is Merlin Medical Limited. It received FDA 510(k) clearance on 2004-07-29 under 510(k) number K031397. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERLIN E-MASK?

MERLIN E-MASK is a medical device that received FDA 510(k) clearance on 2004-07-29. The listed applicant is Merlin Medical Limited. The 510(k) number is K031397.

When did MERLIN E-MASK receive FDA 510(k) clearance?

MERLIN E-MASK received FDA 510(k) clearance on 2004-07-29, under 510(k) number K031397.

Who is the listed applicant for MERLIN E-MASK?

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

What is the FDA product code for MERLIN E-MASK?

The FDA product code for MERLIN E-MASK is CBP.

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 Merlin Medical Limited 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.

K031395MERLIN RESUSCITATOR

Related Devices (Code: CBP)

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.

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)Dehas Medical Systems GmbHK234053F&P Optiflow Flow DiverterFisher & Paykel Healthcare, Ltd.K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic ASK192285CPR Face ShieldFirstar Healthcare Company Limited (Guangzhou)K173770OJR215 Pressure Relief ManifoldFisher & Paykel Healthcare LimitedK171961Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)Xiamen Compower Medical Tech. 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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